The PinPointe FootLaser was the first light-based device to receive FDA clearance to treat onychomycosis (commonly known as nail fungus), and remains one of the only devices on the market today with documented clinically proven efficacy. The PinPointe FootLaser has been found to be an effective alternative to oral medications, which can be risky for the patient. The PinPointe FootLaser has been cleared by the FDA for the temporary improvement in the appearance of clear nail in patients with onychomycosis.

“This is very exciting and an important milestone for NuvoLase and the PinPointe FootLaser.”

“This is very exciting and an important milestone for NuvoLase and the PinPointe FootLaser,” says Steven P. Duddy, President and Chief Executive Officer of NuvoLase Inc. “The PinPointe FootLaser remains the light-based procedure of choice by many clinicians and patients worldwide, and surpassing the 100K procedure mark shows that we are gaining momentum as the acknowledged procedure of choice for onychomycosis.”

Dr. Dan Waldman DPM, Board Certified Foot Surgeon located in North Carolina states, “We have performed thousands of procedures with the PinPointe FootLaser and our patients have been extremely satisfied with the results – they also report that the FootLaser has no side effects, which is important.” He adds, “This breakthrough technology has changed the way we approach patients suffering from unsightly nail fungus and has changed the lives of many of our patients.”

The PinPointe FootLaser is available worldwide, and currently holds approvals including FDA clearances, CE Mark, TGA, and MHLW approval in Japan and Health Canada.

“We’re working to expand to as many markets as possible, both domestically and abroad,” Duddy explains. “We want people all over the world to be able to get the effective treatment that over 100,000 patients have already enjoyed.”

About NuvoLase Inc.
NuvoLase, Inc. develops and markets innovative devices for healthcare providers worldwide. NuvoLase products are the result of solid research, sound science, and extensive clinical experience, ensuring that they always provide superior clinical performance. The PinPointe FootLaser is available worldwide. For more information about laser for toe fungus, visit our website at www.nuvolase.com.

NuvoLase, PinPointe, and PinPointe FootLaser are trademarks of NuvoLase, Inc.

NuvoLase Inc.
11 Ilahee Lane
Chico, CA 95973
530-809-1970

Patients seeking additional information on Treatments for Onychomycosis or a doctor in their area who offers the PinPointe FootLaser procedure can call 1-877-ToeNail (1-877-863-6245) or visitwww.PinPointeFootLaser.com/patients/find-a-provider.

Clinicians interested in learning more about the PinPointe FootLaser or interested in purchasing one for their business can contact NuvoLase’s distribution partner, Cynosure Inc., directly at 800-886-2966 or visit their website at www.cynosure.com.

Contact:
Steven P. Duddy
Phone: 530.809.1970 ext 207
Fax: 866.235.1386
sduddy@nuvolase.com

Click Here to view original Press Release.

“I am pleased and excited about receiving MHLW approval for our PinPointe FootLaser in Japan”, says Steven P. Duddy, President and Chief Executive Officer of NuvoLase Inc. “The PinPointe FootLaser has quickly become the light-based treatment of choice for many clinicians seeking alternative treatment methods for onychomycosis (nail fungus). The FootLaser is an effective alternative to oral medications, which can be risky for the patient.”

The PinPointe FootLaser was the first light-based device to receive FDA clearance specific to onychomycosis, commonly known as nail fungus. With almost 100,000 procedures performed worldwide with the PinPointe FootLaser, the FootLaser remains one of the only devices on the market today with documented clinically proven efficacy.

“I am pleased and excited about receiving MHLW approval for our PinPointe FootLaser in Japan”

The MHLW approval in Japan is the most recent of regulatory clearances for the PinPointe FootLaser, adding to its existing regulatory approvals which include FDA clearances, CE Mark, TGA and Health Canada.

NuvoLase was also recently granted ISO 13485 certification for its Quality Management System, indicating that the company is committed to high design, manufacturing, and production standards for its products and is poised to continue to refine them moving forward.

“We’re working to expand to as many markets as possible, both domestically and abroad,” Duddy explains. “We’ll continue to invest in science, technology, intellectual properties and clinical studies that will help us expand our applications, create new beneficial products, and garner regulatory clearances worldwide.”

About NuvoLase Inc.
NuvoLase, Inc. develops and markets innovative devices for healthcare providers worldwide. NuvoLase products are the result of solid research, sound science, and extensive clinical experience, ensuring that they always provide superior clinical performance. The PinPointe FootLaser Light-based Technology is available worldwide. For more information, visit our website at www.nuvolase.com.

NuvoLase, PinPointe, and PinPointe FootLaser are trademarks of NuvoLase, Inc.

NuvoLase Inc.
11 Ilahee Lane
Chico, CA 95973
530-809-1970

Patients seeking additional information or a doctor in their area who offers the PinPointe FootLaser procedure can call 1-877-ToeNail (1-877-863-6245) or visit www.PinPointeFootLaser.com/patients/find-a-provider.

Clinicians interested in learning more about the PinPointe FootLaser or interested in purchasing one for their business can contact NuvoLase’s distribution partner, Cynosure Inc., directly at 800-886-2966 or visit their website at www.cynosure.com.

Contact:
Steven P. Duddy
Phone: 530.809.1970 ext 207
Fax: 866.235.1386
sduddy@nuvolase.com

Click Here to view original Press Release.

“This certification represents a significant achievement and major milestone for an emerging company such as NuvoLase”

Steven Duddy, President and CEO of NuvoLase Inc., states, “NuvoLase made a corporate decision upon the founding of our organization (approximately one year ago) to obtain certification for our quality system. At that time we recognized the importance of this certification and began the process from the ground up.”

The ISO 13485:2003 certification specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.

“This certification represents a significant achievement and major milestone for an emerging company such as NuvoLase,” adds Duddy. “Successfully completing this process assists us in moving forward with additional regulatory registrations as well as new product development and design.”

About NuvoLase Inc.

NuvoLase, Inc. develops and markets innovative devices for healthcare providers worldwide. NuvoLase products are the result of solid research, sound science, and extensive clinical experience, ensuring that they always provide superior clinical performance. The PinPointe FootLaser is available worldwide. For more information, visit our website at www.nuvolase.com.

NuvoLase, PinPointe, and PinPointe FootLaser are trademarks of NuvoLase, Inc.

NuvoLase Inc.
11 Ilahee Lane
Chico, CA 95973
530-809-1970

Patients seeking additional information or a doctor in their area who offers the PinPointe FootLaser procedure can call 1-877-ToeNail (1-877-863-6245) or visit www.PinPointeFootLaser.com/patients/find-a-provider.

Clinicians interested in learning more about the PinPointe FootLaser or interested in purchasing one for their business can contact NuvoLase’s distribution partner, Cynosure Inc., directly at 800-886-2966 or visit their website at www.cynosure.com.

Contact:
Steven P. Duddy
Phone: 530.809.1970 ext 207
Fax: 866.235.1386
sduddy@nuvolase.com

Click Here to view original Press Release.

Read More

September 12, 2011 –

PinPointe FootLaser, the first light-based device to receive FDA clearance specific to the treatment of Onychomycosis (nail fungus), is recognized by industry leaders as the gold standard product and alternative treatment for those patients suffering from Onychomycosis. With almost 100,000 treatments performed worldwide with the PinPointe FootLaser thus far, the FootLaser is the only device on the market today with documented clinically proven efficacy for the treatment of nail fungus. As part of the transaction NuvoLase also has access to all the regulatory clearances for the FootLaser, including the FDA clearances, CE Mark, TGA and Health Canada.

NuvoLase Inc. also announced today that it has selected a seasoned veteran with significant medical, laser and industry experience to take this business opportunity to new levels. Effective immediately, Mr. Steven P. Duddy has been appointed President and CEO of NuvoLase and will also serve as member of the company’s Board of Directors.

Mr. Duddy commented, “I am both pleased and excited about the opportunity. The PinPointe FootLaser continues to be the product/treatment of choice for those looking for an alternative to risky oral medications.” He added, “Short term, NuvoLase will be focused on expanding market share, both domestically and abroad, and increasing revenue through focused distribution and marketing activities. Longer term, we will utilize the existing technology and intellectual properties as a spring board to grow our product portfolio, thus increasing our overall value to customers, employees, shareholders and investors.”

NuvoLase Inc. operations will be headquartered in Chico, California. Financial terms of the agreement are undisclosed.

About NuvoLase Inc.

NuvoLase, Inc. develops and markets innovative devices for healthcare providers worldwide. NuvoLase products provide superior clinical performance – the result of solid research, sound science, and extensive clinical experience. The PinPointe FootLaser is available worldwide.

NuvoLase, PinPointe, and PinPointe FootLaser are trademarks of NuvoLase, Inc.

Click Here to view original Press Release.

Contact:
Steven P. Duddy
Phone: 530.809.1970 ext 207
Fax: 866.235.1386
sduddy@nuvolase.com

NuvoLase Inc.
11 Ilahee Lane
Chico, CA 95973
530-809-1970

A new modality is certainly called for in the losing battle against this insidious disease, which is prevalent in the population worldwide. Pharmaceutical companies claim that as much as 12% of the population is contaminated with fungal nail disease.

The two cases I report both suggest that tight-fitting shoes can cause intermittent and prolonged trauma that allows the skin defenses to be breached. Revitalization of the local area through compressive exsanguination or tissue injury and continuous trauma to the nail creates sublingual damage, and a nutrient-rich source of decaying matter offers avenues for pathogens to exploit.

Homeopathic and naturalistic remedies such as bleach, tea tree oil, vinegar, thyme, oregano oil, ClariPro, Zetaclear, Antimonolium Curdum, Aloe Vera and mouthwashes rarely work and are mostly a waste of time and money. Pharmacology is normally the most effective treatment for onychomycosis. Over-the-counter (OTC) medication is available in outlets and pharmacies, and the products have had some form of empirical testing and reviews performed by the pharmaceutical industry. Prescription lacquers and oral remedies are example of OTC medication, as are the range of sprays and creams overtly marketed as antifungal medications. The list includes terbinafine, itraconizole, fluconazole, clotrimazole, tolnaftate, zinc undecenoate and undecenoic acid.

The PinPointe FootLaser is the first medical device to obtain regulatory clearance (US FDA, EU, Health Canada, Australia and others) for the safe and effective treatment of onychomycosis. The reported percentage of patients receiving benefit from this treatment, 71.4%, is substantial. [1] Treatment with the FootLaser is repeatable, has no systemic toxicity and laser treatment does not preclude the use of other modalities. [2,3]

In February 2009, I added the FootLaser to my armamentarium of remedies against this stubborn and pernicious disease. To date I have treated over 150 patients. To follow are case reports of two of my patients, both with outcomes that I have not seen before with other forms of therapy.

Independent analysis of data from 109 photos from 60 of my patients was performed in November 2010 and demonstrated: that, at three months, 67% of all treated toes showed improvement, compared with 80% at six months, 68% at nine months and 84% at 12 months. Again, the differences over time possibly reflect different patient populations as well as continued improvement.

Case Study 1

The patient was an active and dynamic smartly dressed, 66-year-old female with pronounced onychomycosis and dystrophyic nails on both feet; the right 1st nail (hallux) being the most severely affected. It was a condition she found embarrassing, uncomfortable, emotionally depressing and cosmetically abhorrent.

In around 2000, whilst out walking in rough adventurous terrain, she damaged both of her great toes to such an extent she feared she would lose them. It would seem that a combination of poor toebox space and slack fastening of the footwear caused repeated compression of the nail plates, leading to subungual trauma and onycholysis.

Over the next two years she noticed that they never fully recovered to their former condition but began to ‘look worse’. The patient presented to a podiatrist in 2008, where routine cutting and thinning of the nails was initiated along with instructions on foot hygiene and advice to use OTC antifungal preparations. Later in 2008, after lab confirmation of dermatophyte infection, the patient was prescribed oral terbinafine.

As a consequence of the medication she developed uncomfortable abdominal swelling, giving her the appearance of being some months pregnant and she found it impossible to remain on the medication longer than two months.

By the time she arrived at my clinic in December 2009 she was disheartened that nothing had worked to eradicate the condition and was emotionally worn down by the effect of having a disfiguring disease (as she saw it). A medical history was documented, her feet were examined and an explanation of the modality of the PinPointe FootLaser was explained.

The patient was reminded of the options available including pharmacological, surgical and FootLaser. I explained the benefit of a toxicity-free approach, the fact that the FootLaser treatment is largely without any sensation, is condensed into the treatment time and has a level of success that surpasses all of the topicals and at least matches the outcome for oral medications, if not more effective. I also explained the need for her to keep her review appointments and that she needed to provide a high level of foot hygiene and antifungal care to prevent recolonisation by opportunistic pathogens. The patient was also informed that recovery is highly variable from patient to patient. Factors such as trauma, poor hygiene, poor circulation, duration and severity of the infection, age and general health may all influence recovery. Finally, I told her that not every condition may resolve and a secondary treatment may be required in about 15-20% of patients. Following this explanation she consented to having the treatment.

The patient’s feet were cleaned and pre-treatment photographs were taken (Figures 1 & 2). All nails were debrided to what I considered an optimal level. As much contaminated tissue needed to be removed as possible and all debris cleared away, including subungual debris. This leaves a good working surface that offers less interference to the laser-energy discharge and penetration into the tissues. However, this is done in a fashion that avoids trauma to the vital soft tissues. Photographs were taken again after debridement (Figure 3).

The FootLaser was methodically and meticulously applied to all nails in a 1mm spot matrix pattern. In addition to the nail plate itself, the nail margins, nail-root matrices and surrounding tissues were also lased. The treatment area extended from approximately 4mm proximal from the eponychium to the end of the nail beds. The pattern was repeated twice over each nail.

Following the laser treatment, terbinafine spray was applied to the nails, toes and interdigital areas and terbinafine cream was applied to the skin on the plantar surfaces to help prevent recolonisation. The post-care advice was explained, and an advice sheet given together with antifungal cream and spray. A letter was sent to her GP detailing the treatment and contact made with her current podiatrist explaining the procedure.

In March 2010 the patient returned for a three-month interim follow-up examination. At this point and it was apparent that there were positive improvements in the nails, although bruising was evident in the nail due to the patient choosing stylish footwear that traumatized the tissues. The right 1st toe was displaying a transverse ridge with dense keratinised tissue distally. All lesser nails showed greater clarity within the structure and they cut with a crisp and clear audible click, indicating improved integrity. The left 1ST nail showed a more normal nail plate production in progress and an advancement of contamination from the nail matrix of 2-3 mm. Importantly, the patient was very happy with the early stages of the treatment. All nails were cleaned and debrided to remove excess keratin and dystrophic nail, and photographs taken. The patient was instructed to continue with her antifungal and hygiene care.

The patient returned in July 2010 for her 7-month progress evaluation and nail care. Once more photographs were taken, the nails reduced, onychophosis and subungual debris removed and 1% clotrimazole spray applied. Photographs of the nails after the reductions were taken. By now the nails demonstrated significant positive change and the most visually abnormal nail had almost grown out.

In October 2010, 10-months posttreatment, the patient requested a second laser treatment ‘to be on the safe side,’ as she put it. I advised that it was unlikely to be necessary but the patient was far happier for me to apply the FootLaser again. This time only the margins and a single pass was performed over all nails. Photographs were taken pre-and post-debridement antifungal spray applied.

In January 2011, 13 months after the initial treatment, the patient once more presented for routine care and an evaluation. Photographs were recorded pre-and post-debridement and 1% clotrimazole spray applied to protect the area. All nails show increased clarity, integrity and health (Figure 1).

Analysis and Discussion

I sent my before and after photographs of the patient’s left and right 1st toes to a research company that uses a trained technician and a computer algorithm to measure the area of clear nail on each image. The results are presented in Figure 4. What is plotted is the percent of clear nail measured from each follow-up photograph before debridement. The left toe (blue) appears stalled at the onset, then, at 7-months it ‘catches up’ with the right. Both nail plates grow clear nail at a rate of about 6% of the nail plate surface per month. This is about the same growth rate as the nail plate itself.

I also noticed from this analysis that the clearing seems to stop at about 80%. Perhaps the continued trauma from tight-fitting stylish shoes is what is preventing the patient’s recovery from reaching 100%, or at least preventing accurate visual confirmation of 100% clearance.

At this point, the evaluation of the nails showed a change in texture vitality and structure. What was once a fungally infected, damaged and gryphotic right first toenail has now returned to an almost normal nail in every way. The patient is enormously happy with her outcome. I am left with the satisfaction that the PinPointe FootLaser has safely and successfully treated her fungal infection and in the process has apparently stimulated a rejuvenation of the nail bed and tissues in the nail root matrix. This is the first time I have seen this to occur in my entire career since graduating in 1981.

Case Study 2

Patient 2 was a physically active working male aged 63 with dystrophic and mycotically infected nails. The infection was clinically restricted to both 1st toes. Dermatophyte infection was confirmed by InTray DM at day 7 following initial assessment, however his physician had also diagnosed it some time before. He was uncomfortable with the thickness of the nails and also dissatisfied by the physical appearance, particularly in barefoot holiday settings. To the best of his recollection he had had his condition for “several years.”

During this time the patient had tried a wide variety of topical, proprietary nail treatments and the condition continued to worsen. He did not consider oral medication as an option that he wished to pursue due to its restrictions on consumables and the impact that had on his lifestyle. Having heard radio advertisements about the new FootLaser, he arrived for treatment at my clinic on 17 November 2009.

His pastimes included competitive squash, extensive hill and robust fell walking. An examination of his footwear indicated the need for a larger size but complications were created by the narrowness of his feet causing difficulties in obtaining the best fit, as length is sometimes sacrificed for a narrower width to ensure better grip on the foot. I explained the need for improved toebox space during the post-laser recovery period.

On examination there was gross thickening of both 1st toe nail plates consistent with prolonged trauma and substantial subungual debris. This material was harvested for culture, which demonstrated dermatophyte contamination by day 7.

A medical history was documented and an explanation of the modality of the PinPointe FootLaser explained. Then the consent forms were completed and pretreatment photographs taken (Figure 5). All nails were extensively debrided and all loose subungual debris removed using clippers and Podospray foot drill with combinations of tungsten carbide burrs.

The FootLaser was methodically and meticulously applied to all nails in a lateral then longitudinal 1mm spot matrix pattern. The nail margins, nail-root matrices and surrounding tissues were lased proximal. Treatment began at approximately 4mm from the eponychium and extended to the very end of the nail beds. All 10 toes were treated and particular attention was applied to both 1st nails. The patient expressed his relief at the procedure being entirely painless.

Following the laser, terbinafine spray was applied to the nails, toes and interdigital areas, and then terbinafine cream was applied to the skin on the plantar surfaces. The post-care advice was explained, and an advice sheet given along with antifungal cream and spray. A letter was sent to his GP detailing the treatment and contact made with his current podiatrist explaining the procedure.

In March 2010 the patient returned for a 4-month post-treatment interim examination. At this point new photographs were taken, and it was apparent that there were positive improvements in the nails. Although the nails were still thick they showed good structural integrity and improved clarity within the structure. When cut, all nails yielded a crisp and clear audible click and had good tensile strength, indicating improved integrity. Both 1st nails showed an improved connection to the nail bed at the distal margin. The nail on the first toe on the left foot showed a visible band of ~3mm width, indicating a difference in its structure compared with the rest of the nail. I speculated that this was perhaps newly re-keratinising nail plate and nail tissue.

All nails were cleaned and debrided to remove excess keratin and dystrophic nail and photographs taken. The patient was instructed to continue with his antifungal hygiene care. The patient was comfortable and satisfied with the look at this early stage.

The patient returned in July 2010, 8months post-treatment for his second progress evaluation, and nail care. Once more photographs were taken, the nails reduced and onychophosis and subungual debris removed and 1% clotrimazole spray applied. Photographs of the nails after the reductions were taken.

By now the nails had already demonstrated significant positive change and most visually abnormal nail had almost completely grown out (Figure 5).

On February 11 2011, 15 months following FootLaser treatment the lesions in most nails had completely grown out. Yet, the computer analysis on this patient returned ‘100% infected’ due to the persistent whitish discoloration. However, this is certainly not the case since the patient is extremely pleased with the overall cosmetic improvement. He has had a lengthy period of time (July 2010 until March 2011) without any clinical interventions of any type and his nails have continued to show improvement in texture, clarity and health. The only negative I can find is the damage done to his nails from impact from his physical activities. I have yet to persuade him that his feet are longer than he thinks.

I am impressed with the changes that occurred in the nails of this patient following one intervention with the PinPointe FootLaser. It has led me to believe that the laser has some other (as yet unknown) rejuvenating influence on the germinating tissues. Although I have no direct evidence, my own personal experience with the laser and my years as a practicing clinician lead me to believe as I continue to work with the laser that I am witnessing treatment outcomes that have not been witnessed before.

References [back to top]

1. Uro M, L Uro, M Abrahams, M Abrahams, R Grzywacz. Safety and efficacy of FootLaser treatment of onychomycosis in private practice. Lasers Surg Med 2011; (S23): 954 (abstr).
2. Abrahams M, Dow H, Grzywacz R, Uro M, Harris DM. Efficacy of FootLaser treatment of onychomycosis in 262 private practice patients. 2011. Pending submission.
3. Harris DM, J Strisower, B McDowell. Pulsed laser treatment for toenail fungus. SPIE Proceedings 7161A121, 2009.

Click on image for larger view

It’s estimated that nearly 35 million Americans suffer from toe fungus, which can lead many to keep their feet under wraps. Prescription-strength and topical medicated polishes work, but now there’s a new way to treat feet.

Why it’s unique: Just about everything can be treated with the zap of a laser and fungus that affects the toe nails is no exception. Harnessing the power of a special-purpose Nd:YAG laser (a technology that doctors use for hair removal, although this one is calibrated specifically for treating nail fungus) the PinPointe laser (it’s the only FDA-cleared device for treating nail fungus) promises relief in as little as a few months, although in some, results may take longer.

“The laser, which also works on fingernails, targets the fungus under the nail that’s in between the nail bed and toe,”

says PinPointe founder and CEO John Strisower.

“The laser alters the environment of the fungus so that the nail plate can outpace the fungal growth. There’s very little pain felt during the half-hour treatment in which we recommend treating all 10 toes so there’s less chance of reinfection.”

Click on image for larger view

Click the image for larger view

The London Nail Laser Clinic

In the United Kingdom, Harley Street is to medicine what Fleet Street is to journalism and Downing Street is to politics. Located in the Central London borough of Westminster, Harley Street is the epicenter of elite medical practice in the UK and is world-renowned as a center of medical excellence.

The London Nail Laser Clinic sits at 10 Harley Street among practices at the forefront of medical science and technological advancements. Its proprietors are Martine and Michael Abrahams, a husband and wife team sharing 24 years of podiatry experience. Almost a year ago they introduced a new specialized treatment to Harley Street. The Abrahams accessed the PinPointe FootLaser™ and began treating toenail fungus.

Michael Abrahams started his first private practice eight years ago in Radlett, a large village north of London where he is based.Martine stopped working after ten years with the National Health Service after having two children. She was ready for a new project now they were both at school.. It was at this time that Michael and Martine first heard about the PinPointe FootLaser™ and thought it could be just the right treatment to bring to the UK. This is their account of how they started The London Nail Laser Clinic and how they continue to run it successfully.

The PinPointe FootLaser™

“In the UK many podiatrists cut people’s toenails, remove hard skin and corns, and that’s generally what we do,” states Martine Abrahams, “but I wanted to do something other than routine podiatry.” Martine had been involved with specialized services and management of podiatry services before the children and was keen to use some of these skills.

“I was trying to find something that would challenge me,” she continued. “Something that that would be exciting and make a name for us.”

In March of 2009 the Abrahams heard about the PinPointe FootLaser™. “We spoke with representatives from PinPointe USA and emailed about ten different podiatrists who had been using the laser,” says Martine. “Dr. Michael Uro [in Sacramento, California] had been doing it with a completely separate company and that seemed to be a good scenario. So we decided to do it and thought Harley Street would be the right location and the right environment.”

New Business Preparation

Before the Abrahams went to America to be trained on the laser system, they contacted a creative consultant, a PR agency, and a media planner. “They helped us develop a messaging ladder, and the name and branding for the London Nail Laser Clinic,” explains Michael. “They produced a press release for us and approached various newspapers, magazines, editors, and journalists. So we knew what was involved, what we’d be spending, and what kind of media was out there to utilize.”

Soon the Abrahams realized that most of their efforts would come through paid advertising, so their media planner produced a six-month plan in various local papers, national papers, and national magazines. “At the same time,” says Martine, “the creative consultant produced a website for us which was very comprehensive and on the same level as a branded cosmetic company. The whole idea was to say, ‘this is all we do.’”

Marketing Mix

The Abrahams say they see about 40% of their patients via Internet advertising. “We also advertise in the free newspapers given to commuters on the underground and the trains,” explains Martine. “Their readership is about 2 million in London. Quite expensive, but we always seem to get a response from it. When we have an advert, the phones ring and we see our web hits go from 30 or 40 to 200 or even over 00 on some occasions. We’ve also done a whole host of magazines, local and national papers.”

“In terms of frequency,” adds Michael, “we’re probably doing an ad in a commuter paper twice a month, a national paper once or twice a month, and probably every two months we’re doing a magazine.”

Customer Response

The Abrahams were surprised at how far away people come to have the treatments. “We’ve had patients from Switzerland, Scotland, Munich, Singapore, Spain, Italy, and Israel,” says Martine, “so there’s a whole host of people who use the internet to look up fungal nails!. We also provide a zero-percent finance program so people can pay in installments without paying any interest. That opens up the market to those who don’t immediately have the money without risk to us.”

Inquiries And Consultations

“When people call with inquiries we spend the time – about ten minutes – to talk through the procedure,” states Michael. “We explain the cost of what’s involved and what we do, so when they come in for a consultation they have a pretty good idea that they’re going to go ahead with the treatment.”

“We’ve had over 800 telephone calls and 350 emails inquiring about the treatment,” adds Martine. “Of those 1,150 inquiries we’ve treated over 250 patients so over 20% of the inquiries have resulted in treatments. We also have a toll-free call answering service that provides some basic information and takes messages and then we call the clients back.”

“We do offer a free consultation. We allow an hour and a half for the consultation and the treatment. By the time we discuss it with the patient, thin down the nails and do all that, it’s about 40 minutes. And then by the time we lase all the nails it can be another 40 minutes”.

Future Plans

The Abrahams are looking at expanding. “We’ve had meetings with a private clinic in Notting Hill that offers a whole host of services,” says Martine. “They cover four locations in London so we’re looking at doing laser treatments there. We’re advertising in London anyway so we’d like to utilize the laser in as many locations as we can.”

“The other thing we’re looking forward to,” adds Michael, “is creating a name for ourselves in this specialized field. We’ve already had a dermatologist who’s referred two or three patients to us. We’ve had phone calls from various doctors wanting to refer patients to us for treatment or finding out more.”.” “Now we have seen results ourselves, we can go and spread the word” he added.

Professional Satisfaction

“This has been a very exciting experience,” states Martine. “It’s very nice changing the way you work and having the opportunity to be involved in cutting edge technology, at the forefront of a new treatment.”

“I saw a patient for a four-month review,” recalls Michael, “and she was literally jumping for joy as I said, ‘Yes, it’s improving.’ She was so thrilled. It was just amazing. It’s very satisfying to be able to do that.”

“Also, I think podiatrists here often don’t take the lead in many things. Every so often there are articles about foot-related issues and it’s a physical therapist or an occupational therapist or someone else talking about it, not a podiatrist. So it’s nice to be actually doing something for a condition that other specialists don’t treat, and is a very unique, very podiatric-based problem. No one else deals with fungal infections well so it’s nice to be involved with that and be able to treat it.”

Benefits To The Practice

“One of the nice things is that, as this gets busier, I’ll be able to happily pick and choose what I do and when I work in my general practice,” says Michael. “It gives me a little bit more freedom. Also my non-patient contact time is far more valuable now than it ever has been. To spend twenty minutes on the phone returning an inquiry call is potentially more profitable because if they come in for a treatment, that’s £750 ($1,225) compared to a normal fee in the practice.”

“So obviously there’s the financial element,” adds Martine, “but putting that to the side, there’s also the issue of raising the level of the practice. Offering a treatment like this potentially makes our practice stand out from other practices. If you’re looking for a new podiatrist, the fact that we offer something unique could be a selling point or a reason to choose us.”

Efficacy

It can take eighteen months or more for a new big toenail to grow out so full results will take time. Of the patients we have treated and returned for review after four months we believe 78% have an easily noticeable improvement in the nails.

In any event, the athletes foot, often present on the skin has resolved, the nail condition improves and the patients feel their feet are healthier. They are certainly taking far better care of them than they ever used to.

Our aim of making people feel happy and proud of their feet is now within reach. Feet should not be hidden away but allowed to be healthy and free. I think we would all like to feel this way – and now for many hundreds and thousands of people they can.”

Given the prevalence of onychomycosis and the emergence of laser therapy, these panelists review their approaches to managing onychomycosis, discuss ethical considerations with non-FDA approved modalities and emphasize the importance of establishing realistic patient expectations.

Q: In this current environment with no new antifungal drugs having been released in years, all previous agents now being generic, a lack of sales representatives calling on podiatry and little discussion of the topic at CME meetings, has your approach to the treatment of onychomycosis changed?

A: The majority of the panelists say their approach to onychomycosis has not changed. Allen Jacobs, DPM, FACFAS, says this is particularly the case when it comes to treating onychomycosis in patients with diabetes mellitus. Dr. Jacobs notes that researchers have demonstrated that onychomycosis and tinea pedis increase the risks of cellulitis, ulceration and gangrene. [1] He adds that terbinafine (Lamisil, Novartis Pharmaceuticals) has been proven to be safe and effective in patients with diabetes. [2,3]

Bryan Markinson, DPM, FASPD, says he has “always” been satisfied with the results of oral terbinafine and continues to be satisfied.

“In my opinion, (terbinafine) remains the only agent that reliably gets results in the highest percentage of patients with little side effects in relation to the number of uses in clinical practice worldwide for many years,” maintains Dr. Markinson.

Richard Pollak, DPM, MS, FACFAS, says he uses quite a bit of oral antifungals and predominantly uses oral terbinafine. While he has used oral itraconazole Sporanox, Ortho-McNeil/Janssen Pharmaceuticals) in the past, Dr. Pollak says he utilizes oral terbinafine 95 percent of the time for moderate to severe onychomycosis. Adam Landsman, DPM, FACFAS, PhD, notes he has “always had moderately good success” with terbinafine and continues to recommend this for his patients on a regular basis. However, Dr. Landsman points out the recurrence rate frequently turns patients away from this treatment.

Given the availability of generic terbinafine, Drs. Jacobs and Landsman note the drug has become much more accessible to patients due to a significant decrease in cost.

Since the article on intermittent pulse dosing by Zaias and Rebell in 2004, Dr. Markinson uses pulse dosing of oral terbinafine as opposed to 90-day continuous dosing. [4]

“This method uses 70 percent less drug and is 95 percent as effective as 90-day continuous dosing,” notes Dr. Markinson.

That said, Dr. Landsman says two-thirds of his patients with onychomycosis reject oral terbinafine due to continued fears about liver injury or an unwillingness to take pills for 90 days.

More recently, Dr. Landsman has started to recommend laser treatment but he notes that cost still remains an issue for many patients. Conversely, Dr. Landsman notes that many new patients have sought out his practice, specifically to get laser treatment.

Mark Kosinski, DPM, FIDSA, says many DPMs were so “heavily indoctrinated” during the marketing heyday of drugs like oral terbinafine and ciclopirox (Penlac, Sanofi-Aventis) that there has been an “autopilot” approach to onychomycosis. Dr. Kosinski says the

routine approach to onychomycosis has involved oral therapy, topical therapy, debridement or some combination of the three until the recent introduction of laser therapy.

Dr. Kosinski says he first learned about laser therapy from radio ads and patient inquiries. When he went to look for the research to support the anecdotal claims, Dr. Kosinski was disappointed to find “few, if any, large scale, randomized clinical trials.

“In todayʼs world, we have to be careful not to let commercialism and public pressure drive medical decision-making,” emphasizes Dr. Kosinski.

On a related note, Dr. Jacobs says the less frequent discussion of onychomycosis and tinea pedis at scientific sessions in podiatry “is more a reflection of the corporate dependency, which our scientific sessions have developed, rather than a reflection of the real needs of our profession in terms of daily practice.” That said, Dr. Jacobs notes that he has attended several recent podiatric meetings at which onychomycosis has been the subject of discussion. He adds that onychomycosis continues to be discussed at scientific sessions in dermatology.

Dr. Jacobs says the converse is also true.

“We have been advised by corporate sponsored ʻexpertsʼ over the years to utilize various modalities for the treatment of onychomycosis which, in hindsight, were ineffective or minimally effective at best,” points out Dr. Jacobs. “I would suggest that absent such speakers from our meetings, we are now in a position to critically analyze what really works. I have always found it intriguing that with all the fungal nails and tinea pedis that present to the offices of all podiatrists daily that the overwhelming majority of literature on the subject of onychomycosis calling for treatment comes from dermatology literature and not podiatry literature.”

Q: What percentage of onychomycosis patients in your practice do you manage with debridement alone, with topical agents, with oral agents or with a device (i.e. laser)? Relating to the first question, do you feel this has changed for you in the past few years?

A: “Onychomycosis is a dermatological disease that deserves treatment,” notes Dr. Kosinski. “It is our practice to institute some form of medical therapy for those patients whom we feel have the best chance of achieving some benefit.”

Dr. Kosinski says any percentages in regard to onychomycosis treatment are relative to demographics and vary from practice to practice. Additional patient factors would include: the severity and degree of affected nails; patient age; and the medical status of the patient.

Dr. Kosinski estimates that 60 percent of his patients with onychomycosis receive medical treatment while 40 percent receive debridement alone. The patients who only receive debridement include those who are either unable or unwilling to have systemic therapy, and those with severe onychomycosis who would not benefit from topical therapy, according to Dr. Kosinski.

“Palliation is aimed at keeping the patient comfortable and preventing complications, especially in our diabetic population,” explains Dr. Kosinski.

Dr. Markinson says 95 percent of his elderly patients with onychomycosis receive debridement only. Dr. Pollak says at least 50 percent of his patients whom he is treating with debridement only are okay with that.

Dr. Jacobs adds that debridement by itself provides only debulking of the nail and resultant nail bed pressure relief. He says it contributes to the resolution of onychomycosis only in combination with oral therapy. Dr. Landsman usually recommends either oral treatment or laser therapy, and will employ debridement as part of a regular treatment regimen.

Dr. Pollak notes that he still uses oral terbinafine extensively. However, he concedes that at least 50 percent of his patients with onychomycosis are diabetic and many of them are not interested in oral agents. Dr. Kosinski concurs.

“Many times, we think we have a candidate for systemic therapy only to find out the patient has a history of liver disease or is taking medication which would be incompatible with oral agents,” notes Dr. Kosinski. “This is not uncommon in our particular patient population.”

When it comes to his patients in the 30 to 50 age group with onychomycosis, Dr. Markinson says about a third of these patients receive oral terbinafine. He says the rest of the patients may opt for any of the available topicals, either over-the-counter (OTC) or prescription, but notes that his “experience with completion of treatment in these cases is rare.” While Dr. Pollak does not feel that a topical antifungal such as ciclopirox is effective for patients with moderate to severe onychomycosis, he says it does have a place in the treatment of mild onychomycosis.

Dr. Jacobs counters that no topical agents have proven to be effective for the clinical and mycologic cure of onychomycosis. When patients with onychomycosis initially present for treatment, Dr. Jacobs obtains a fungal histology and cultures. He does employ 40% urea cream to facilitate lysis of the nail plate from the nail bed. Dr. Jacobs says this permits aggressive removal of infected nail plate material. Subsequently, Dr. Jacobs utilizes topical antifungal therapy for the exposed nail bed in combination with oral antifungal therapy, typically terbinafine.

When it comes to laser therapy, Dr. Jacobs says there is currently no evidence of clinical or mycologic cure in the long term. He notes that he has not incorporated laser therapy into his practice at this time due to the initially reported results of laser therapy demonstrating only temporary improvement and the significant financial cost to the patient.

“I would think that ethical practitioners utilizing this modality would advise those patients paying for such therapy that the ultimate cure rate is unclear and that repeated laser management may very well be required,” maintains Dr. Jacobs.

Dr. Kosinski says he has used the PinPointe FootLaser (PinPointe) for the past year at the New York College of Podiatric Medicine. “Right now, we are trying to gauge exactly how well it works and where it best fits in with the other treatments,” adds Dr. Kosinski. Dr. Markinson does not currently use laser therapy but he says this is more of a business decision related to being in a hospital-based practice where dermatology colleagues and lasers are readily available.

Q: What are your thoughts on the onslaught of non-FDA approved treatment, including topical agents and devices, for onychomycosis that are being marketed to the profession? Which, if any, have you used? What sort of success are you finding? How do you define “success” in these patients?

A: Dr. Jacobs says he does not utilize newer therapies with “unproven benefit” to the patient for the management of onychomycosis. For example, Dr, Jacobs notes that shoe disinfection techniques with chemical agents or ultraviolet light reduce the fungal load within the shoe, but have not been demonstrated to reduce the risk of re-infection.

Dr. Markinson notes the commercial success of the “onslaught” of non-FDA approved therapies is dependent upon clinician rejection of using systemic therapy. While he notes that clinicians overwhelmingly attest that systemic therapy offers the best results for onychomycosis, Dr. Markinson says they may not employ systemic therapy due to “overstated safety concerns.” Nevertheless, Dr. Markinson says anecdotal evidence from both clinicians and patients support varying degrees of clinical success with these non-FDA approved agents.

“Due to the low morbidity associated with onychomycosis in otherwise healthy patients and the emphasis on clinical success over negative mycology, I have no real problem with the use of these (non-FDA approved) agents,” notes Dr. Markinson.

Dr. Kosinski concurs. If the products are not considered harmful and patients are informed that the products are not FDA-approved, Dr. Kosinski doesn’t have a problem with patients seeking out these therapies.

“I find nothing wrong with patients trying them,” explains Dr. Kosinski. “What I do have a problem with is patients paying for expensive treatments (by companies) that make unrealistic claims.”

Dr. Jacobs concurs. He says ciclopirox topical nail lacquer was an example of ineffective therapy, “which never had any compelling data to support the cost of the agent.”

Dr. Kosinski says the Tetra Corporation has an interesting marketing strategy in that the company offers a 100 percent money-back guarantee with its Formula 3 product.

“If it works, great. If it doesn’t, the patient is not out any money. I cannot see a downside,” notes Dr. Kosinski. “However, I again inform the patient as to the general success rate of topical agents before beginning treatment.”

Being in a hospital-based practice, Dr. Markinson does not sell products. However, he has been informed recently that the Tetra Corporation plans to support a clinical trial on the Formula 3 product that will focus on clinical cure. “To my knowledge, this is the only company so far willing to do so,” adds Dr. Markinson.

Although Dr. Landsman rarely recommends topical agents, he says nearly all of his patients with onychomycosis have tried topical agents. He says tea tree oil is the most common treatment but his patients have also tried bleach, ciclopirox and even Vicks Vaporub. Dr. Landsman notes he has not found any of these to be effective so he rarely recommends them. He does note, however, that sometimes regular treatment with these agents causes some softening of the nails and this may be beneficial for reducing the risk of onychocryptosis.

Overall, the success of any topical for onychomycosis is dependent upon the severity of the disease and patient adherence, according to Dr. Kosinski.

“The very fact the patient has to apply (the topical) daily for months on end usually dooms it to failure,” claims Dr. Kosinski. “This coupled with the fact that topicals work best (when they work) on mild disease has put my personal success rate below 5 percent.”

While Dr. Landsman notes he has witnessed the benefits of laser therapy for onychomycosis, he is “very disturbed” about the influx of new, untested devices.

“In my opinion, many device manufacturers are making unfounded claims of efficacy, based primarily on the wavelength(s) selected,” explains Dr. Landsman. “I feel that they are intentionally clouding the waters by ignoring pulse train patterns, energy density and all of the other parameters that will influence the outcomes. They are so anxious to get to market quickly that they are sidestepping the normal testing and approval process. It costs a lot of money to test these devices so if you are paying a small amount to get a laser, chances are that the price reflects that lack of clinical trials.”

Dr. Pollak notes that one of the companies manufacturing laser therapy devices has been aggressive in marketing not only to the profession but to the patient population as well. He says he sees a newspaper ad for laser treatment every three days. Dr. Pollak says the marketing of laser therapy has been successful in bringing in patients who are looking for either a cure or a substantial improvement.

Dr. Jacobs says laser therapy for onychomycosis remains unproven and it has not been demonstrated to reduce the risk of re-infection.

While Dr. Pollak has used laser therapy, he only did so in a research setting so he declines to comment on whether the modality was successful. However, Dr. Pollak says success “doesn’t necessarily have to be a complete cure.” He says a complete cure would be a toenail with negative KOH, negative fungal culture and complete eradication of the fungus. However, this “pinnacle of success” remains elusive for any single modality, according to Dr. Pollak.

“Even as successful as Lamisil was, (complete cure) only occurred in 38 percent of the patients studied and it only occurred in 14 percent of patients treated with Sporanox,” points out Dr. Pollak. “So if one defines success as a perfectly healthy toenail without laboratory evidence of fungus, the highest current benchmark is 38 percent, which, depending on your perspective, could not be considered very high.” [5,6]

Dr. Pollak says a more “practical” definition of success is a substantial improvement of the nail from baseline. In the oral terbinafine and itraconazole trials, Dr. Pollak says researchers looked for 5 mm of healthy toenail growth from baseline. [5,6]

“The thought process was if you allow the nail to grow out, ultimately it would continue to grow out without fungus,” adds Dr. Pollak.

Dr. Kosinski agrees there are varying perceptions about what constitutes success in onychomycosis treatment. While he says the optimal goal is complete resolution 12 months after the beginning of treatment, Dr. Kosinski feels success is any improvement in the appearance of the nail after treatment.

“I base it on clinical rather than mycological criteria since appearance is what the patient is concerned about,” notes Dr. Kosinski. “Each patient has his or her own definition of success, however. This is why realistic treatment goals must be fully discussed with the patient prior to embarking on therapy.”

Q: Pursuant to the previous question, do you see any ethical/moral issues with dispensing or utilizing — at sometimes significant out of pocket cost to the patient — a product or device without FDA approval or any supportive clinical trials for the treatment of onychomycosis?

A: From his vantage point, Dr. Jacobs finds no ethical dilemma in dispensing and selling anything that would be prescribed in any event. However, he says there are some instances when profit motive takes priority over patient need. Dr. Jacobs adds that this problem is not unique to the podiatry profession.

In regard to the dispensing of unproven agents or therapies, Dr. Jacobs says if a practitioner has a “reasonable basis for belief that a particular agent will indeed be of benefit to a patient,” then the clinician should proceed accordingly.

“One must remember that practitioner experience is also a part of evidence-based medicine,” maintains Dr. Jacobs.

Dr. Markinson says he sees “far more ethical/moral problems” with everyday approved products like durable medical equipment (DME), internal fixation and orthotics “that really accrue some outrageous unnecessary expenditures with questionable need” than anything he has seen in regard to topical agents for onychomycosis.

Dr. Pollak says he has ethical and moral issues about attracting patients to one’s practice with the perceived promise of toenail fungus removal when there is no clinical trial proof that the treatment would work. He says clinical trials are essential to prove a product or medication works.

“The cost of some of these (laser) treatments could be $800 to $1,000. It is a costly treatment,” notes Dr. Pollak. “The concern is if the treatment is not effective, what do you do when the patient comes back a year later and his or her nail is no better than it was? I think that is a moral concern. Of course, no one can guarantee results any more than you can guarantee results from a surgical procedure.”

Drs. Kosinski and Landsman say adequate disclosure is the key. Problems arise when the patient is not fully informed, according to Dr. Kosinski.

“The more a patient pays out of pocket, the more he or she will expect results,” emphasizes Dr. Kosinski. “Patients are paying to achieve the ideal result they have in their minds.”

Dr. Kosinski says it is important to establish realistic expectations with the patient.

“It is our duty to inform the patients, in realistic terms and in a way that they can understand, the odds for improvement,” notes Dr. Kosinski. “That goes for whether or not the treatment is covered by the patient’s insurance. If the patient begins treatment knowing his or her odds for improvement, and elects to go through with the treatment even in the face of out of pocket payment, then the patient does so with open eyes.”

In his experience, Dr. Landsman has found that cost does not seem to be a barrier for patients suffering with onychomycosis. He says they are looking for a solution and are willing to pay if the treatment works.

In regard to laser therapy, some studies are available with devices such as the Noveon (Nomir Medical) and PinPointe FootLaser so at least there is a basis for treatment and discussion of outcomes, according to Dr. Landsman. [7,8] For most of the other laser devices without FDA clearance, Dr. Landsman says podiatrists have to ask themselves whether they would use these devices to treat members of their family, knowing that there “is almost no data to support the safety and efficacy.” Dr. Landsman asserts that all lasers are not interchangeable based on wavelength and improperly delivered energy can potentially burn the nail bed, disfigure the nail matrix and cause the nail to loosen or fall off.

Q: Now that the PinPointe Foot Laser has received FDA clearance for the temporary clearing of fungal toenails and there is a good chance more cleared lasers are to follow (assuming the FDA logjam has broken down), what impact do you think laser therapy will have in podiatric practice?

A: Oral and topical therapies will remain the “predominant forms of treatment” for onychomycosis for two reasons, according to Dr. Kosinski. He says the first reason is ease of treatment as anyone with a prescription pad can treat onychomycosis. Dr. Kosinski also notes these therapies are for the most part covered by insurance with little or no out of pocket expense for the patient.

Dr. Kosinski says access to laser therapy now and for the foreseeable future will be limited to doctors who are willing to lease or purchase laser devices, and by a patient’s willingness to pay out of pocket for an expensive treatment. However, if it can be proven that laser therapy has higher efficacy than oral antifungal therapy, Dr. Kosinski says laser therapy would have the potential to become the more dominant mode of treatment.

Dr. Jacobs says laser therapy will remain attractive to those who can afford it.

“We live in a time when ‘anti-aging’ therapies, pharmacologic agents, plastic surgery and cosmetics are in great demand,” points out Dr. Jacobs. “There is a large market for such therapies among those unaffected by the current economic environment. … However, honest and ethical representation of what might actually be expected from such treatment modalities should be a priority.”

Drs. Landsman and Pollak say podiatric physicians want to offer treatments that will work and documented evidence goes a long way in this regard.

“The FDA clearance for the PinPointe FootLaser is important because it says the evidence of efficacy was strong and it spells out what the clinician should expect when he or she treats with this device,” says Dr. Landsman. “Due to the high risk of recurrence, the current wisdom is that onychomycosis is not cured but rather controlled. The FDA clearance of the PinPointe FootLaser indirectly references this by stating that this device has been shown to clear these infected nails.”

Dr. Markinson counters that the verbiage of the FDA clearance for this device (“temporary clearing of fungus toenails”) is “anemic.” He notes that the issues at the FDA that resulted in this weak clearance are complicated and beyond the scope of this article.

That said, Dr. Markinson says he has been involved with the development and clinical trials of a laser currently on the market. He says the results are impressive and may even be as good as oral therapy, both in clinical improvement and negative mycology. For now, Dr. Markinson says laser therapy for onychomycosis offers clinicians a cash basis alternative and removes the side effect issues of oral therapy. However, Dr. Markinson emphasizes that more research is needed to ascertain the benefits of each individual laser modality and, similar to the other panelists, expresses concern about marketing claims that are not backed up by evidence.

“We will not know for some time how effectively each laser that gets approval will work until larger numbers of cases are completed,” says Dr. Markinson. “I am concerned that if current marketing techniques regarding the use of laser continue, it will only be a matter of time before FDA enforcement and many of our colleagues are staring into each others’ eyes. If that happens, we lose.”

Dr. Jacobs is a Fellow of the American College of Foot and Ankle Surgeons, and the American Professional Wound Care Association. He is in private practice in St. Louis.

Dr. Kosinski is a Professor of Podiatric Medicine at the New York College of Podiatric Medicine. He is a Fellow of the Infectious Diseases Society of America and the New York Academy of Medicine.

Dr. Landsman is an Assistant Professor of Surgery at Harvard Medical School and the Chief of the Division of Podiatric Surgery at Cambridge Health Alliance. He is the Director of Research at the California School of Podiatric Medicine at Samuel Merritt University. Dr. Landsman is a Fellow of the American College of Foot and Ankle Surgeons.

Dr. Landsman is a paid consultant for PinPointe USA and previously served as a paid consultant to Nomir Medical Technologies.

Dr. Markinson is the Chief of Podiatric Medicine and Surgery in the Leni and Peter W. May Department of Orthopedic Surgery at the Mount Sinai School of Medicine in New York, N.Y. He is a Fellow of the American Society of Podiatric Dermatology. Dr. Markinson is an advisor to and shareholder of Shoe Care Innovations, the manufacturer of the Steri-Shoe. He is also a member of the podiatric advisory board for Nomir Medical Technologies.

Dr. Pollak is a Diplomate of the American Board of Podiatric Surgery and is a Fellow of the American College of Foot and Ankle Surgeons. He has been a principal clinical investigator in over 80 clinical trials. Dr. Pollak is in private practice in San Antonio.

Dr. Joseph is a consultant in lower extremity infectious diseases and is a Fellow of the Infectious Diseases Society of America. He is affiliated with the Roxborough Memorial Hospital in Philadelphia. Dr. Joseph has disclosed that he is a member of the podiatric advisory board for Nomir Medical Technologies.

References

1. Boyko EJ, Ahroni JH, Cohen V, Nelson KM, Heagerty PJ. Prediction of diabetic foot ulcer occurrence using commonly available clinical information: the Seattle Diabetic Foot Study. Diabetes Care. 2006:29(6):1202-7. [back]
2. Pollak R, Billstein SA. Safety of oral terbinafine for toenail onychomycosis. J Am Podiatr Med Assoc. 1997;87(12):565-70. [back]
3. Farkas B, Paul C, Dobozy A, et al. Terbinafine (Lamisil) treatment of toenail onychomycosis in patients with insulin-dependent and non-insulin-dependent diabetes mellitus: a multicentre trial. Br J Dermatol. 2002;146(2):254-60. [back]
4. Zaias N, Rebell G. The successful treatment of Trichophyton rubrum nail bed (distal subungual) onychomycosis with intermittent pulse-dosed terbinafine. Arch Dermatol. 2004:140(6):691-5. [back]
5. Terbinafine package insert, Novartis Pharmaceuticals. [back]
6. Itraconazole package insert, Ortho-McNeil/Janssen Pharmaceuticals. [back]
7. Landsman AS, Robbins AH, Angelini PF, et al. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure. J Am Podiatr Med Assoc. 2010;100(3):166-77. [back]
8. Harris DM, McDowell BA, Strisower J. Laser treatment for toenail fungus. Proc SPIE 2009;7161A:1-7. [back]

Dr. David Helfman, CEO of Village Podiatry Centers states,

“After extensive research we have chosen to offer the PinPointe FootLaser treatment to our patients suffering from nail fungus. PinPointe is currently the only company who has demonstrated important safety and clinical efficacy in a large multi-site study and is the only company that has received clearance from the FDA and Health Canada for its device for the respective application.”

John Strisower, CEO and Chairman at NuvoLase, Inc. states,

“We are thrilled to be working with David and Village Podiatry Centers as we roll out service in the major metro market areas of Atlanta and Macon. David and his team at Village have earned a reputation for providing unsurpassed quality of care, the same quality of care we take pride in offering both patients and our Providers.”

About Village Podiatry Centers

Village Podiatry Centers is the largest foot and ankle surgical practice in Georgia with 35 podiatric surgeons. Patient care is provided in 28 offices located in the metro Atlanta and Macon regions. Surgery is performed at more than 25 hospitals and ambulatory surgery centers. More information can be found online at http://www.villagepodiatrycenters.com.

About NuvoLase, Inc.

NuvoLase, Inc., Chico, CA, develops and markets innovative laser-based devices for the treatment of infections by healthcare providers worldwide. The PinPointe FootLaser is the only device cleared in the US and Canada specifically for Onychomycosis (nail fungus) and is available for purchase globally. All PinPointe products provide superior clinical performance, the result of years of research, sound science and clinical studies. Patients seeking additional information or a doctor in their area offering the PinPointe FootLaser procedure, call (877) ToeNail or (877) 863-6245 or visit nuvolase.com/patients/find-a-provider. Clinicians interested in becoming a PinPointe provider, call (530) 809-3800 or visit NuvoLase.com.

“David’s peers have acknowledged his valuable contributions as a professor, scientist, clinical researcher, and author as a result of his election to this prestigious society. We are very proud of him and his appointment and wish to congratulate him on this latest accomplishment.” stated John Strisower, founder and CEO of PinPointe USA Inc.

About American Society for Laser Medicine and Surgery

The American Society for Laser Medicine and Surgery, Inc. (ASLMS) was founded in 1980 and is the world’s largest professional organization dedicated to promoting excellence in patient care by advancing laser applications and related technologies.

For more information visit www.ASLMS.org.

About NuvoLase, Inc. NuvoLase, Inc., Chico, CA, develops and markets innovative laser-based devices for the treatment of infections by healthcare providers worldwide. The PinPointe FootLaser is the only FDA and Health Canada cleared device for treating nail fungus and is available globally. All PinPointe products provide superior clinical performance, the result of years of research, sound science and clinical studies. Patients seeking additional information or a doctor in their area offering the PinPointe FootLaser procedure, call (877) ToeNail or (877) 863-6245 or visit nuvolase.com/patients/find-a-provider. Clinicians interested in becoming a PinPointe provider, call (530) 809-3800 or visit NuvoLase.com.

Nail fungus can severely damage your nails, leaving them discolored, jagged, and brittle. While nail fungus is often attributed to poor hygiene, the fungi capable of causing this condition are present in nearly every environment. In most cases, the immune system is able to fight and destroy these fungi. It is when a person’s immune system is compromised that this fungi can take over and lead to this condition. The elderly are most at risk, especially those with weakened immune systems, decreased blood circulation, and diabetes. Moist and humid environments are also a risk, such as a communal shower at a gymnasium or pool. These moist environments can even include socks and shoes that do not absorb perspiration or allow for proper air flow. People with athlete’s foot and psoriasis are also at increased risk.

There are many ways to combat nail fungus. Be sure to wear socks that are breathable, such as those made out of natural fibers. When in a communal shower or other wet area, be sure not to walk barefoot. In the case that you have a nail injury, pay careful attention that it stays clean and dry so that it may heal without any fungi entering it. Also, give your shoes a break every few days and let them air out. For those who partake in salon pedicures and manicures, be sure to go to a clean and reputable one. Most places will even allow you to bring your own files and clippers.

Even with these precautions, fungi may still strike your nails. It is important to treat this condition as early as possible. One infected nail is much easier and cheaper to treat than five or ten. Nail fungus can cause serious problems in people with diabetes, AIDS, leukemia, or those who have had an organ transplant. These problems may include decreased circulation to the nerve supplies to the feet or even cellulitis, a bacterial infection of the skin.

Once you have nail fungus, no amount of scrubbing or soap will destroy it. Oral medications work, at best, 50-60% of the time and have potential risk to your liver, kidneys, retina, and taste buds. Topical medicines can be a hassle to apply and must often be used in conjunction with oral medication. Laser treatment is one of the most effective ways to deal with this condition. This method is painless and requires no anesthetic. A single treatment can be completed in less than an hour. Find a Provider near you today.

NuvoLase, Inc., makers of the PinPointe FootLaser, announced today that Adam Landsman DPM will head up the company’s Medical Advisory Panel. In this role Dr. Landsman will provide valuable insight as it pertains to current and future clinical applications, clinical studies as well as assist with recommendations on expanding the panel into multi-disciplinary specialties thus broadening the company’s expertise.

John Strisower, CEO and Chairman at NuvoLase, Inc. states,

“We are thrilled to have someone of such high caliber agree to head up our Advisory Panel. We view the panel as the gateway to the future. Adam is known and respected worldwide by his peers for his in-depth podiatric clinical and practical knowledge particularly as it pertains to Onychomycosis.”

Adam Landsman, DPM, PhD, FACFAS is currently an Assistant Professor of Surgery, Harvard Medical School, Boston, MA and is also the Director of Research for the California School of Podiatric Medicine at Samuel Merritt University, Oakland, CA. In addition to his clinical experience Dr. Landsman has traveled globally lecturing on many topics including Onychomycosis.

Dr. Landsman commented,

“I am delighted to join the team in this capacity. PinPointe has long been seen as the global leader in the light-based treatment of Onychomycosis. The FootLaser has quickly become the gold standard for many and PinPointe is focused on all the right things in order to maintain their leadership position.”

About PinPointe USA, Inc.

PinPointe USA, Inc., located in Chico, California, develops and markets innovative laser-based devices for the treatment of infections by healthcare providers for patients worldwide. The PinPointe FootLaser is available globally.

All PinPointe products provide superior clinical performance which is the result of years of research, sound science and clinical studies. For patients wanting additional information or to find a doctor in their area offering the PinPointe FootLaser procedure, call (877) ToeNail or (877) 863-6245 or visit nuvolase.com/find. For clinicians interested in becoming a PinPointe provider, call (530) 809-3800.

Summer is coming, along with open-toed shoes, flip-flops, bare feet, and — of course — the beach.

If that first sentence fills you with fear, that’s just not fair. Summer is all about health, celebration of your natural beauty, and the glory of what you were born with. There is nothing like losing your self-consciousness and inhibition and walking hand-in-hand over the sand with the one you love (or even someone you are just getting to know) — it is not a time to be worried about your toes!

In our last post we focused on the science of nail fungus: what causes it, how to prevent it, and why it sticks around so long once you have it. This time around, we wanted to take a look at the effects of that little secret this time of year, with spring flowers finally beginning to bloom, gyms everywhere crammed to capacity, and summer just around the corner.

In summer, if you really want to enjoy the season, there is nowhere to hide thick yellow nails. Sure, you can avoid open-toed shoes, flip-flops, sandals, and all the other special footwear that comes back into fashion each April or May, and lingers as long as the season.

Or you can do what you used to do, before you got that unappealing thickening and discoloration in your toenails, and fully enjoy the season.

Remember the days when you just enjoyed being barefoot, or wearing open-toed shoes? Remember the first summer you noticed discoloration, when you tried to get rid of it through tried-and-true methods like soap and water, only to realize you would need to keep your little piggies covered that year? Maybe you tried oral anti-fungals, putting your renal system at risk, and ended up with only partially clear toenails, or even no improvement at all… and decided it was time to give up on your little toes and the summer footwear that made them happiest.

Now is the time to turn back the clock.

Whether you are 16 or 60, your nail fungus problem need not keep your toes out of sight this summer–or next. Find a provider near you and take back the summer!

Dr. Gary Evans, New York City foot doctor, demonstrates a promising new treatment for fungus-free feet on Good Morning America.

Leading foot doctor in NYC, Dr. Gary Evans, demonstrates the PinPointe FootLaser system on Good Morning America to show the benefits of fungus-free feet. The Food and Drug Administration cleared the use of the PinPointe FootLaser system, which has been available in the United States since 2008. This podiatrist in NYC uses this treatment because it is painless and side-effect free.

While this laser toenail treatment in New York City takes less than a half hour, results are not immediate as the toenail will grow out normally in 9 to 12 months. The PinPointe FootLaser is said to be 88 percent effective, proving to be better than anything else on the market for foot fungus elimination.

“It was a great honor to be able to perform the PinPointe FootLaser treatment on “Good Morning America” and allow millions of viewers to see that they no longer have to live with unsightly foot fungus. The PinPointe FootLaser allows me to effectively treat my patient’s feet and eliminate their toenail infection,” said Dr. Gary Evans, NYC podiatrist.

Dr. Evans is an experienced and highly qualified podiatrist in New York City. Offering a wide array of services, the full-service practice is committed to providing the highest quality of foot and ankle care. Services include treatments for Achilles tendon, flat feet, bunion care, bunion surgery, laser treatment of nail fungus, geriatric foot care and heel pain in NYC. Additionally, Dr. Evans and his professional staff also offer a complete x-ray facility, shockwave therapy for heel pain, diagnostic ultrasound and PinPointe Laser.

Dr. Gary Evans and Dr. Korponay are part of the first group of trained and certified PinPointe FootLaser podiatrists in the New York City area. This exciting breakthrough in treatment for millions of Americans that suffer from a toenail fungus infection has proven clinical results. Visit Dr. Gary Evans, NYC podiatrist, for fungus-free feet with the use of this NYC laser toenail treatment and watch him perform this procedure on “Good Morning America” via the practice’s website.

“It is important to bring the best in quality foot and ankle health care procedures to my patients. With the PinPointe foot laser treatment, my patients can have their fungus eliminated more safely and easier than ever before. Our practice strives to remain on the cutting-edge of technology advances for the best possible podiatric care available,” stated Dr. Gary Evans, NYC podiatrist.

Pesky toenail fungus can be unsightly, irritating and even painful. With the latest in New York City laser toenail treatment, patients can now reclaim their toenails and eliminate uncomfortable toenail fungus without the use of anesthetics or oral medications. The use of the PinPointe FootLaser provides patients relief from their foot fungus.

About Dr. Gary Evans’ Podiatric Practice

Dr. Gary Evans is a board certified podiatrist in New York City and an NYU graduate. Specializing in all phases of podiatry, Dr. Gary Evans is joined by Drs. James Korponay and Caren Schumer for the best in quality care. Offering a wide array of foot and ankle care in a convenient and comfortable setting, this NYC podiatrist provides treatment for bunions, diabetic foot care, heel pain, and Achilles tendon, among many other foot conditions. Website: www.drgaryevans.com

John Strisower CEO, PinPointe USA says, “We are extremely pleased about the Health Canada clearance. As with our US clearance we were able to obtain this clearance by providing compelling data regarding the product’s safety and efficacy.”

Fungal nail infection is estimated to affect more than 10 percent of the North American population – more then 35 million people. This condition is caused by fungus under the nail. As they grow, fungi feed on keratin, the tough protein that makes up the hard surface of the nails. The nail becomes darker in color and debris may accumulate under the nail. And the infection may spread to other toenails, the skin or the fingernails or even other people. Nail infection can cause nails to be discolored, thickened, brittle, and ‘crumbly’ and in some people it can interfere with wearing shoes and/or cause pain when walking.

Mr. Strisower continues, “We are pleased with the continued global acceptance of the FootLaser procedure from both a clinical and patient perspective. To date, the FootLaser is quickly approaching 100,000 procedures. This impressive growth indicates the FootLaser’s acceptance and ability to address an unmet need.”

The PinPointe FootLaser is already available commercially in the US and in the European Union under a CE Mark for the treatment of nail fungus, and is TGA-approved and available in Australia and New Zealand.

About PinPointe USA, Inc.

PinPointe USA, Inc., located in Chico, California, develops and markets innovative laser-based devices for the treatment of infections by healthcare providers for patients worldwide. The PinPointe FootLaser is available globally. All PinPointe products provide superior clinical performance which is the result of years of research, sound science and clinical studies.

For patients wanting additional information or to find a doctor in their area offering the PinPointe FootLaser procedure, call (877) ToeNail or (877) 863-6245 or visit nuvolase.com/patients/find-a-provider. For clinicians interested in becoming a PinPointe provider, call (530) 809-3800 or visit PinPointeUSA.com.

Affiliated Podiatrists, LTD, Chicago podiatrists, are now offering advanced toenail fungus removal with PinPointe FootLaser.

Dr. Feder of Affiliated Podiatrists, LTD, an experienced podiatrist in Chicago, is pleased to offer PinPointe FootLaser in Chicago for eliminating foot fungus. PinPointe FootLaser is a patented laser that is specially designed to penetrate through the toenail and eradicate the fungal spores in the nail bed that are causing toenail infection.

PinPointe FootLaser in Chicago can safely treat nail fungus while significantly reducing nail infection. Patients can treat their toenail infections more conveniently and comfortably with this Chicago laser toenail treatment. For patients who are tired of discolored, thick toenails, the PinPointe FootLaser creates a quick, effective solution to foot fungus.

“It is important to bring the best in quality foot and ankle health care procedures to my patients. With the PinPointe foot laser treatment, my patients can have their fungus eliminated more safely and easier than ever before. It is my pleasure to remain on the cutting-edge of technology advances for the best possible podiatric care available,” said Dr. Marc Feder, podiatrist in Chicago.

Affiliated Podiatrists, LTD is the first practice to bring the PinPointe FootLaser treatment to the Chicago area, making them the patient’s source for PinPointe Foot Laser toenail treatment for fast and effective nail fungus relief. PinPointe FootLaser has recently been cleared by the FDA and approved for its efficacy against nail fungus.

For generations, Affiliated Podiatrists, Ltd have been solving the Chicagoland and Near North nail fungus and foot problems. Dr. Feder and his team of professionals are experienced and qualified to treat and diagnose a wide array of foot and ankle conditions. Providing specialized treatments, including PinPointe FootLaser in Chicago, Affiliated Podiatrists Ltd. is capable of transforming any foot condition into healthy, happy feet. Specialties of this practice include elimination of foot and ankle pain, surgical repair of bunions, hammertoes, and ingrown nails, along with many other ailments.

Patients who are looking for quality foot and ankle health care turn to Affiliated Podiatrists, Ltd, Chicago podiatrists, for the best in quality treatment available. Further proof of the commitment to provide quality care is seen through Chicago PinPointe FootLaser treatment.

About Affiliated Podiatrists, Ltd: Affiliated Podiatrists, Ltd. are leading podiatrists in Chicago, serving patients throughout the Chicagoland area and the Near North neighborhood. The original practice, established in 1945 by Dr. Harold Feder is now continued by his sons, Drs. Marc and Joel Feder at the Six Corners Medical Center. Offering an array of podiatric services, including laser fungus treatment, Affiliated Podiatrists, Ltd., Chicago podiatrists, continues to satisfy its’ patients foot and ankle needs- time and time again.

Say Goodbye to Embarrassing Toenail Fungus with New PinPointe FootLaser

Toenail FungusCharacterized by thick, unsightly, discolored nails, fungus-infected toenails can be irritating, embarrassing and painful. For years, the only treatments available for toenail fungus were topical and oral medications or removal of the nail. Typically, the medications were largely ineffective and removal of the nail plate was painful and debilitating.

Fast, Effective and Pain Free Nail Fungus Treatment from Dr. Perlstein

A new breakthrough in technology is making it possible to get rid of your nail fungus fast- a new procedure known as PinPointe FootLaser. The new, patented laser technology treats nail fungus safely and quickly with no drugs, no anesthesia and no pain. It’s specially designed to penetrate your toenail, vaporizing the fungus embedded deep in your nail bed. Better yet, the powerful laser beam targets the infection only and has no effect on surrounding healthy tissue. In just one appointment at our Brooklyn NY office we can treat your nail fungus, and within months following the treatment, the toenail will replace itself with a healthy, clear, fungus free nail.

Avoiding Irritating Toenail Fungus

Prevention is key to avoiding a fungal infection. The following tips can help you avoid toenail fungus.

• Practice good hygiene and inspect feet and toes regularly
• Try not to injure your nail by cutting it too short, as trauma to the nail may lead to infection
• Wear moisture wicking socks
• Wear dry, proper-fitting shoes that allow air to circulate around your feet
• Wear shower sandals when you are at a public pool or shower

Left untreated, a fungal infection can spread to other toenails, the skin on the feet and even the fingernails. Severe cases can impair one’s ability to walk or lead to painful ingrown toenails. It’s important to seek care when you notice signs of infection.

If you’re ready to eliminate your toenail fungus, contact our Brooklyn NY office and learn more about the new PinPointe FootLaser. We can evaluate your fungal infection and make recommendations for best treating and eradicating your toenail fungus once and for all.

FDA Clearance for the Treatment of Nail Fungus (Onychomycosis).

Offers New Treatment Option for More Than 35 Million Americans with the Condition

CHICO, CA – October 20, 2010 – NuvoLase, Inc., a leader in podiatric light-based therapy, announced today the PinPointe™ FootLaser™ received clearance from the U.S. Food and Drug Administration (FDA) for the treatment of nail fungus (onychomycosis). During the procedure, which is administered by podiatrists, a specially-designed laser beam is directed across the nail. The laser penetrates the nail bed targeting the fungi responsible for the infection, while leaving the nail and surrounding healthy tissue intact.

Fungal nail infection is estimated to affect more than 10 percent of the U.S. population – or 35 million Americans. This condition is caused by fungus under the nail. As they grow, fungi feed on keratin, the tough protein that makes up the hard surface of the nails. The nail becomes darker in color and debris may accumulate under the nail. And the infection may spread to other toenails, the skin or the fingernails. Nail infection can cause nails to be discolored, thickened, brittle, and ‘crumbly’ and in some people it can interfere with wearing shoes and/or cause pain when walking.

“Toenail fungus is an incredibly embarrassing chronic condition affecting millions of people worldwide that genuinely impacts a person’s quality of life. For some with diabetes or immune disorders nail fungus can lead to serious health problems,” said Dr. Adam Landsman, Assistant Professor of Surgery at Harvard Medical School and Chief of the Division of Podiatric Surgery at Cambridge Hospital in Massachusetts. “With the clearance of the PinPointe FootLaser, patients finally have a pain-free treatment option that is more successful than topically-applied antifungal drugs, safer than oral medication, and less painful than surgical removal of the nail.”

The treatment of nail infection is difficult because the infection is under and inside of the nail. This makes it hard for any treatment to reach and destroy the infection. Some people are treated with medicated nail polish or oral medications, which can be associated with side effects and serious drug interactions. Another option is to surgically remove the nail. Many people also try bleach, vinegar, mouthwash or household cleaners – home remedies that ultimately do not resolve the problem.

“NuvoLase submitted clinical evidence to FDA demonstrating that after a single treatment, between 68 percent and 81 percent of patients experienced increased clear nail at six and 12 months and 81 percent of all patients had sustained improvement at 12 months. Now, a single 30 minute treatment can be done comfortably in the privacy of a doctor’s office without the need of anesthesia,” says John Strisower, founder and Chief Executive Officer of PinPointe. “Our goal is continued market leadership of podiatric light-based therapeutic technology.”

The PinPointe FootLaser is also sold in the European Union under a CE Mark for the treatment of nail fungus, and is TGA-approved and available in Australia and New Zealand.

About NuvoLase, Inc.

PinPointe USA, Inc., located in Chico, California, develops and markets innovative laser-based solutions for podiatrists and patients worldwide. The PinPointe FootLaser for treating nail fungus and other conditions is available in nearly every major metropolitan area in the United States. All PinPointe products provide superior clinical performance which is the result of years of research, sound science and clinical studies.

For patients wanting additional information or to find a doctor in their area offering the PinPointe FootLaser procedure, call (877) Toe-Nail or (877) 863‑6245 or visit nuvolase.com/find. For podiatrists interested in becoming a PinPointe provider, call (530) 809‑3809 or visit NuvoLase.com.