SanuWave: A Novel Approach to Diabetic Foot Ulcers, and a $20BN Chronic Wound Market

How SanuWave’s Novel Technology DermaPACE Spearheads a New Wave of Investigative Device Evaluation (IDE) Treatments, and the Impact on the Medical Device Companies

Investors and company executives may be “shocked” to learn that the chronic wound market size is estimated at $20 billion,  according to the Advanced Medical Technology Association (“AdvaMed”).  This figure stems from the cost of management and treatment of chronic and complex wounds just in the United States alone.
Further, AdvaMed estimates that 1.5 million diabetic foot ulcers occur annually, leading to over 82,000 amputations, at a direct and indirect cost ranging from $20,000 to $60,000 per patient. Chronic leg wounds (ulcers) account for the loss of two million workdays per year, at a cost of approximately $300 million in lost productivity.

Alpharetta, Ga.-based SanuWave (SNWV) looks to reduce that sticker shock.  The company is developing potentially game-changing extracorp real shock wave technology for chronic wound care, cardiovascular, neurological and orthopedic conditions: its portfolio of shock wave therapies that sends ‘shockwaves’ through damaged cells, an action that stimulates the healing process. Through its Pulsed Acoustic Cellular Expression (PACE), the most advanced among these shockwave therapies is the DermaPACE, used in the treatment of the aforementioned chronic foot ulcers.

Significant trial data indicates DermaPACE was effective in healing diabetic foot ulcers. The main hurdle to clear will be hitting the 100% wound closure threshold. While not attained in the initial pivotal study, this may very well be able to be done with additional DermaPACE treatments.  SanuWave aims for 100% wound closure by week-12.  Assuming success in the trial, FDA approval may be possible before the end of 2014 going into 2015, serving what Zacks Small Cap Research describes as an “underserved” $2 billion market, which has seen more coverage and activity recently.

SanuWave is up over 101% in 1 yr, over 400% this year.  Zacks Small Cap Research has a price target of $1.30 for the stock, which may be a very conservative estimate.

SanuWave has positioned itself, upon receiving Investigational Device Exemption designation (a suggestion that the FDA has not ‘red-flagged’ past data), as a significantly undervalued plays in the medical device market.

Important clinical developments that have been made since Q4 2012 going into the first part of 2013 add to the company’s long-term investment potential: trial site selection; IRB approvals and a new CRO with specialization in wound trials for the supplemental dermaPACE clinical trial; a new CEO; additional financing raised; and the ongoing expansion of the company’s sales and distribution channels both in the U.S. and abroad.

Joseph Chiarelli, the new Chief Executive Officer of SANUWAVE, commented that “during 2012, we made progress in establishing SANUWAVE as the world leader in shock wave technology. Recently we refocused our business strategy with the goal of utilizing our non-invasive shock wave technology to address large market opportunities and to broaden the value potential of our patent portfolio to evaluate both medical and non-medical uses of our technology.”

As to this point, the potential and effectiveness of devices with the Investigational Device Exemption (IDE) designation and how they change the orphan medical device markets that they serve should position the company favorably upon entrance in trials, scheduled for mid-2013, according to the company.

An IDE permits use of a device in a clinical investigation to evaluate the safety and/or efficacy of the medical device. The IDE will be “considered approved” and used as part of trials in support of either a Pre-Market Approval (PMA) application or a Pre-Market Notification, code 510(k) submission to the FDA.

The regulatory path for IDE devices involves the formal approval process of the FDA of the safety and effectiveness of the medical device based on valid device-related scientific data and rational, rather than just comparison — as in the 510(k) process. This process mostly applies to Class III medical devices with the most novel and complex technologies and applications; hence they are subject to rigorous scrutiny and testing by the FDA.

Despite a longer investigation period than 510(k), companies in recent years have once again favored seeking PMA through IDE for the ability to gather more data for use at marketization, and for the clearer path to approval.

This strategy of bolstering pre-market data by pursuing non-510(k) approval routes have contributed to substantial growth for the medical device sector among both smaller and larger companies. Further, as the efforts of large companies to aggressively enter wound care show, SanuWave is well positioned to enjoy success at market. The following companies are case studies of the market responding well to companies that have recently adopted the PMA strategy and have actively entered the regenerative medicine medical device market.

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Smith & Nephew (SNN) has begun to make impressive strides in its pursuit of being a wound care market leader.  Its PICO system is designed for chronic, acute and traumatic wounds, along with sub acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts and closed surgical incisions.

A study presented by Lindsey Bullough and Diane Wilkinson of the Royal Albert Edward Infirmary in Wigan in the UK followed a group of 50 clinically obese patients who were deemed to be at higher risk of contracting an infection after having a C-section, and had their closed surgical incisions treated with a protocol including the PICO Negative Pressure Wound Therapy System.  The result showed no infections, along with zero re-admissions. This is among one of the more exciting developments in bioactives, the fastest growing segment of the wound care market.

Smith & Nephew has started to shift its focus to its advanced wound management franchise, away from its traditional orthopedic market, which has become quite crowded.  The acquisition of Healthpoint (a privately held company focused on the development and commercialization of novel, cost-effective bioactive solutions for debridement, dermal repair and regeneration) for $782 million in November of 2012 has allowed the company to take advantage of such growth. This acquisition has been one of the drivers of Smith & Nephew’s stock taking off this year, as with the rest of the regenerative medicine sector.

HealthPoint’s flagship product is Collagenase SANTYL® Ointment (“SANTYL”), an enzymatic debrider used for dermal ulcers and burns.  Healthpoint’s portfolio also includes the OASIS® family of leading acellular skin substitutes for venous leg ulcers and diabetic foot ulcers and REGRANEX®, a growth factor for treating diabetic foot ulcers. The HealthPoint acquisition is forecast to generate around $190 million in sales in 2012 from its existing range of products, driven by SANTYL.  Healthpoint has a strong R&D portfolio with its lead product candidate entering Phase 3 trials for the treatment of leg ulcers, a large potential opportunity in the same vein (no pun intended) as SanuWave.

“We are committed to innovation that helps reduce the human and economic cost of wounds,” said Tom Dugan, President of North American Advanced Wound Management division at Smith & Nephew.  “PICO, OPSITE and ACTICOAT are examples of Smith & Nephew’s unique ability to provide a spectrum of wound care options that together give clinicians the flexibility to exercise their best judgment and to develop better ways to serve patients.”

One of the main drivers behind Smith & Nephew’s 15% stock price increase so far this year has been its expansion into the wound care market.  As the HealthPoint acquisition has shown, Smith & Nephew may also choose to join the chorus of larger companies that may look to acquire smaller companies to further cement new lines of revenue in the space. It is not unreasonable to think at least one of these prime candidates may be SanuWave.

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Medtronic (MDT) submitted Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) to support the study of the Symplicity renal denervation system for the treatment of uncontrolled hypertension in patients with systolic blood pressure between 140-160 mm Hg, despite treatment with numerous anti-hypertensive medications of different classes. Currently the Symplicity renal denervation system is only available for investigational use in the United States.

Metronic tapped into the potential of the renal denervation market when they acquired California-based Ardian for $800 million in 2010. Ardian developed the Symplicity renal denervation system after completing animal studies and after a completed proof-of-concept in a 45-patient first-in-man trial.  The company believes it will receive approval for the Symplicity device by 2015.
Medtronic’s global renal denervation clinical program include more than 250 patients already enrolled in the Symplicity HTN-1 and Symplicity HTN-2 studies, 530 patients being enrolled in the Symplicity HTN-3 study, and 5,000 patients being enrolled in the Global Symplicity Registry.

The success of this venture certainly has contributed to the stock’s 20% rise since last year, although some believe that the Ardian acquisition was overpriced, given that company executives acknowledge that the Symplicity system is still in its infancy.  This surmises the notion that Medtronic may join the bustling M&A activity in medicine with an eye towards another acquisition.

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InVivo Therapeutics (NVIV) recently passed one of the company’s two proposals under review with the FDA.  InVivo announced this month it had received the Humanitarian Use Device (HUD) designation in April, 2013 for the company’s potentially revolutionary biocompatible polymer scaffolding (BPS) device to treat acute spinal cord injuries. HUD designation covers devices that treat rare, ‘orphan’ diseases or conditions.

The National Spinal Cord Injury Statistical Center (NSCISC) estimates some 12,000 individuals will become fully or partially paralyzed each year due to spinal cord injury. InVivo’s data from the company’s previously completed primate studies from 2008 have been published in the Journal of Neuroscience Methods, and the company won the prestigious 2011 Apple Award from the American Spinal Injury Association recognizing excellence in spinal cord injury research.

Frank Reynolds, InVivo CEO, spoke of the success of the HUD designation as “important not only for speed-to-market, but it represents a benchmark in InVivo’s commitment to patients with SCI.”

InVivo is also exploring IDE designation for its drug delivery hydrogel for both spinal cord injury and peripheral nerve pain. Hydrogel would be regulated as a device by the FDA, allowing InVivo to move into an IDE program in spinal cord injury and peripheral nerve pain in late 2013 or 2014 and file for approval under the PMA pathway, potentially in 2016 or 2017. InVivo plans to file an IDE application to the FDA to start the first-in-human studies before the end of the year.

InVivo’s opportunity is through its injectable hydrogel to complement the polymer scaffolding   Methylprednisolone, which is FDA-approved, and is currently used to treat spinal cord injuries and is used to treat peripheral nerve injuries. However, high-dose intravenous administration of the drug can result in harmful side effects, including the increase in the risk of pneumonia, sepsis and mortality. InVivo believes that by precisely controlling the release of methylprednisolone at the site of injury, dosage can be delivered to the point of inflammation while mitigating the risk of harmful systemic side effects while being therapeutically effective
InVivo has been a sleeper hit for 2013, with the stock up over 60% this year; some 15% of that comes off the HUD designation announcement.

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The FDA’s 510(k) policy is being called into question as a “broken” system, most notably in 2011 by Dr. David R. Challoner,  Chair of the Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Board on Population Health and Public Health Practice at the Institute of Medicine of The National Academies. This unease gives rise to the notion of IDE as an alternative to the 510(k), especially when it comes to testing the effectiveness of sophisticated and orphan medical devices.

Not only have these four companies shown an alternative path to 510(k), but they have shown themselves to be quite successful with IDE, giving the medical device industry a new avenue in which to prosper.

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