SANUWAVE Health Announces Regulatory Clearance for dermaPACE in Mexico by the Federal Commission for Protection against Sanitary Risks (COFEPRIS)

Rhea-AI Summary

SANUWAVE Health (OTCQB: SNWV) has formed a joint venture with MEDSTENT, S.A. to market its dermaPACE® System for treating chronic wounds in Mexico. This system, cleared by COFEPRIS, addresses diabetic foot ulcers, venous and arterial ulcers, and post-surgical wounds. The partnership aims to leverage MEDSTENT's expertise in the Mexican healthcare market to enhance access to this innovative treatment. The wound care market in Mexico is expected to grow at a CAGR of 6.72% over the next five years due to an aging population and increasing chronic wounds.

Positive

• Received COFEPRIS clearance to market dermaPACE® System in Mexico.
• Joint venture with MEDSTENT facilitates access to the Mexican healthcare market.
• Wound care market in Mexico projected to grow at a CAGR of 6.72%.

Negative

• None.

Forms Joint Venture with MEDSTENT, S.A. to Market dermaPACE in Mexico to Treat a Variety of Chronic Wounds

SUWANEE, GA, Oct. 14, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire -- SANUWAVE Health, Inc. (OTCQB: SNWV), focused on the development and commercialization of a robust and innovative advanced wound care product portfolio for the repair and regeneration of skin and vascular structures, announced today that the Company has received regulatory clearance from the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) to market its proprietary dermaPACE® System to treat a variety of chronic wounds in Mexico, including diabetic foot ulcers (DFUs), venous and arterial ulcers, and post-traumatic and post-surgical wounds. 

In addition, SANUWAVE announces the formation of a joint venture with MEDSTENT, S.A. de C.V. for the exclusive rights to market and distribute the dermaPACE® System as a treatment for chronic and acute wounds in Mexico in exchange for joint profit sharing.

"COFEPRIS clearance to market dermaPACE® in Mexico is a key achievement in our global expansion strategy and represents our second distribution agreement in the Latin America region.  We look forward to working with MEDSTENT to bring our non-invasive shockwave technology to the millions of patients across Mexico who suffer with unhealing, chronic wounds. The MEDSTENT team has considerable experience and expertise in introducing and marketing innovative medical products in Mexico where more than 50% of the population has access to public healthcare. We believe that MEDSTENT’s knowledge of the Mexican market, its vascular sales teams and distribution centers will be very beneficial for successful market entry, especially to the governmental hospitals, which are the dominant healthcare provider in Mexico in general and specifically when it comes to the treatment of advanced wounds," stated Kevin A. Richardson, II, Chairman and Chief Executive Officer of SANUWAVE Health. 

“Incorporating SANUWAVE’s dermaPACE® System into MEDSTENT medical products portfolio allows us to leverage our experience in the vascular surgery markets in Mexico.  We are creating a wound care specialty within our vascular expertise and this joint venture with SANUWAVE provides us with a broad offering for vascular surgeons, who also treat these recalcitrant, chronic wounds,” noted Daniel Capuano, Chief Executive Officer of MEDSTENT.  “We look forward to partnering with SANUWAVE and expect a successful launch of this end-to-end wound care offering in Mexico, where limited effective treatment options can often lead to lower limb amputations.”

About Chronic Wounds in Mexico

In Mexico, the compound annual growth rate (CAGR) in wound care in general is projected to be 6.72% for the next five years.  The key contributors to the market growth are an increasing older population and the growing burden of chronic wounds.  According to the National Council for the Evaluation of Social Development Policy 2018, approximately 7.8% of the Mexican population are aged 65 and above.¹ The International Diabetes Federation data, the prevalence of diabetes among Mexican population aged between 20 and 79 years was approximately 10.8% in 2010 and significantly increased to 13.5% in 2019.  Furthermore, it is well known that chronic venous disease (CVD) is a prevalent disease in the Mexican population. Up to 67.8% of Mexicans have some degree of the disease, and out of those, according to the Vein Consult Study, 2.5% of them have Stages C5 and C6, which makes them prone to develop chronic venous ulcers.²  Currently, there are no effective curative treatments for various chronic wounds being utilized in Mexico, which has led to high rates of lower limb amputations. 

About the dermaPACE® System

The dermaPACE® System is a novel medical system based on shockwave technology, which has been used for nearly 30 years in lithotripsy procedures (destruction of kidney stones) and later in orthopedic treatments.  These early lithotripsy and orthopedic devices provided the earliest evidence that there was an effect on wound healing. Pulsed Acoustic Cellular Expression (PACE®) Technology was developed based on this evidence, and the dermaPACE® System is the first to utilize PACE-specific proprietary protocols for wound treatment.  The dermaPACE® System treatment must be administered by a healthcare professional.  The dermaPACE® System is FDA cleared for the treatment of diabetic foot ulcers (DFU) and it is the first and only system based on focused electrohydraulic shockwave principle cleared by the FDA for such indication.   For international markets, the dermaPACE® System is CE Marked in Europe for advanced wound care indications and in Canada carries a Health Canada Medical Device class II License. The dermaPACE® System is currently licensed or approved for advanced wound care indications in Brazil, Mexico and dozens of countries and regions around the world. 

About MEDSTENT, S.A. de C.V.

MEDSTENT, headquartered in Mexico City, Mexico, is a biomedical products and service provider in the Mexican medical community. MEDSTENT achieves its commitment by supplying top quality service and products in order to build a transcending relationship “supplier-doctor-patient” as a result of the synergy between “service, products and people.” MEDSTENT has been active in the Mexican medical market since 1995 and its main directors each bring more than 40 years of experience to their roles.  The company has built a strong relationship with its clients in the public and private sectors. MEDSTENT contributes to the patients’ wellbeing, health and quality of life by distributing high quality medical devices and services according to ISO 13485 and ISO 9001 driven standards as well as domestic and international regulations.  The Company prides itself on the constant improvement of its quality systems, which aim to surpass our customers’ expectations.

MEDSTENT is constantly seeking for innovative technologies to serve the Mexican medical market. It is a pioneer in the Cardiovascular field and works with and offers service directly to Vascular Surgeons involved in Wound Care treatment. 

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) (www.SANUWAVE.com) is focused on the research, development, and commercialization of its patented noninvasive and biological response activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.  Through its recent acquisition of Celularity’s UltraMIST® assets, SANUWAVE now combines two highly complementary and market-cleared energy transfer technologies and two human tissue biologic products, which creates a platform of scale with an end-to-end product offering in the advanced wound care market. 

SANUWAVE’s portfolio of regenerative medicine products and product candidates activate tissue regeneration biological signaling and angiogenic responses, producing new vascularization and microcirculatory improvement combined with tissue growth which helps restore the body’s normal healing processes. SANUWAVE applies and researches its patented energy transfer technologies in wound healing, orthopedic/spine, plastic/cosmetic and cardiac/endovascular conditions.

For additional information about the Company, visit www. www sanuwave.com.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

Contact:

SANUWAVE Health, Inc.
Kevin Richardson II
Chairman and Chief Executive Officer
978-922-2447
investorrelations@sanuwave.com

Anne Marie Fields

Managing Director

Rx Communications Group

afields@rxir.com

¹ https://www.mordorintelligence.com/industry-reports/mexico-wound-care-management-devices-market

² https://doi.org/10.1016/j.jvs.2019.08.143

FAQ

What is the significance of the joint venture between SANUWAVE and MEDSTENT?

The joint venture allows SANUWAVE to leverage MEDSTENT's market expertise to distribute the dermaPACE® System for chronic wounds in Mexico.

What conditions can the dermaPACE® System treat?

The dermaPACE® System is designed to treat various chronic wounds including diabetic foot ulcers, venous and arterial ulcers, and post-surgical wounds.

When did SANUWAVE receive regulatory clearance for dermaPACE® in Mexico?

SANUWAVE received regulatory clearance from COFEPRIS on October 14, 2020.

What is the expected growth rate of the wound care market in Mexico?

The wound care market in Mexico is expected to grow at a compound annual growth rate (CAGR) of 6.72% over the next five years.

How does the dermaPACE® System work?

The dermaPACE® System utilizes shockwave technology to promote wound healing and is the first FDA-cleared device for treating diabetic foot ulcers.