LOS ANGELES, CA, April 25, 2022 (GLOBE NEWSWIRE) -- Endonovo Therapeutics, Inc. (OTCQB:ENDV) today announced an agreement with NAMSA – a leading Global Contract Research Organization (CRO) and medical device reimbursement specialist – as strategic advisors to develop in-patient and out-patient medical reimbursement strategies for Endonovo’s flagship PEMF (Pulsed Electro-Magnetic Field) product SofPulse®.
“Engaging NAMSA as strategy advisors to develop and apply proven medical device reimbursement strategies is a huge advantage for Endonovo and our shareholders, according to Endonovo CEO Alan Collier. “NAMSA is a proven medical device development partner with relevant therapeutic know-how that is critical when seeking acceleration of reimbursement efforts and commercialization objectives,” he pointed out.
NAMSA was founded in 1967 as a scientific research company and later transitioned into a Global CRO and Medtech (Medical Technologies) reimbursement specialist. Today, it has 1,000 strategic associates who provide Medtech reimbursement advisory expertise to more than 300 clients in 15 global regions.
NAMSA offers a full continuum of reimbursement services for medical technologies. Their reimbursement consultants provide: payer relations, medical policy research, coverage advocacy, Healthcare Common Procedure Coding System (HCPCS), Current Procedural Terminology (CPT) code analysis/applications and health economic analysis.
“Our team strives to bring impactful products like the Endonovo SofPulse into higher adoption. With this technology, and its favorable economics, there are multiple opportunities ahead for serving populations in need. We will work together with the Endonovo team to improve market access for this novel device in the very near term.”, stated Joseph Sierra, Director, Reimbursement Consulting, North America, NAMSA
NAMSA provides strategic guidance and tactical support to fast-track medical device commercialization and to make an immediate impact on patient healthcare worldwide. NAMSA’s services have grown to include regulatory, reimbursement and quality consulting as well as clinical research. These additions have helped NAMSA to become the pre-eminent 100% medical device-focused Global CRO that offers proven strategic solutions throughout the full development continuum. NAMSA is the only US FDA ASCA accredited medical device biocompatibility laboratory in the world. This allows medical device sponsors to fast-track commercialization efforts, while achieving time and cost efficiencies in every major market of the world.
Collier stated: “We are fortunate to be working directly with Joseph Sierra, at NAMSA. With over 10 years of reimbursement experience, and his proven track-record in developing successful medical device reimbursement strategies is exemplary and will be helpful in developing the path toward reimbursement for our main product SofPulse®. Joseph is an adjunct instructor at USC (University of Southern California) Masters of Health Administration Program, and his prior professional work includes successful stints with NeoFect USA and Medtronic Ltd. where he demonstrated a record of success leading roles in reimbursement programs, analysis, and strategies for their medical devices.”
NAMSA’s reimbursement expertise and track-record in the introduction and adoption of medical devices into multiple medical specialties includes: orthopedics, cardiovascular surgery, general surgery, plastic surgery, neurology, robotic surgery and wound care. Collaborating with NAMSA on global reimbursement allows Endonovo to explore reimbursement for the U.S. medical markets as well as the European Union market adoption through SofPulse® medical CE Mark (CE518057). Additional target markets would be Taiwan and other Asian countries.
NAMSA advisory services are all designed to increase payer retention and include:
- Reimbursement Assessment: Identify appropriate coding, coverage and payment for medical device coverage and reimbursement. All medtech reimbursement in the U.S. is determined through the proper use and application of HCPCS and CPT Code Analysis and Applications. In the U.S., NAMSA has successfully guided clients to achieve new codes through the American Medical Association (AMA) CPT™ process or the Centers for Medicare and Medicaid (CMS) HCPCS Workgroup process.
- Reimbursement Guides: Provide guidance to hospitals and physicians for proper billing and coding of medical device products. These guides assist hospitals and physicians to understand the likely level of payment for the services associated with new technologies, thereby supporting device adoption.
- Conferences with Hospitals and Medical Industry Payors: Streamline adoption and reimbursement of medical devices to hospitals and payors to assess adoption and projected margins for securing reimbursement from CMS Medicare and private payors.
- Development of Clinical and Pre-Clinical Trials and Studies: Setup trials and studies to support hospitals’ and medical payors’ need for specific efficacy outcomes to support reimbursement for medical devices and large scale adoption and coverage by medical facilities and payors.
- Health Economics Analysis: Work with medtech companies with varying types of analyses which may be required to demonstrate cost effectiveness and to accelerate favorable medical policy coverage through the following activities:
- Cost Effectiveness Analysis (CEA) is used to evaluate the relative cost of new technologies or treatments and is critical to payers when new treatments are more expensive, but more effective;
- Cost Minimization Analysis is used when a new treatment is less expensive and at least as effective;
- Budget Impact Mode: is a comprehensive study of third-party payer payments, technology costs and savings that will result from the adoption of the proposed technology.
- FAQs for Payers and Sales Staff: Assist companies in creating a list of frequently asked questions for payers and sales staff to help communicate key information for use by hospitals and physicians when billing for new technologies and services.
- Path To Surgical Standard of Care Adoption: Develop better ways to present medical device products, efficacy, manuals and cost analysis models to hospitals and payors for commercialization and adoption.
NAMSA global clinical research experts have conducted the following clinical studies over the last few years:
- Completed over 450 customized orthopedic preclinical studies worldwide;
- Supported over 300 clinical device trials per year (and 300 customized preclinical studies) in the areas of cardiology and peripheral vascular devices; and on average, 40% of the clinical studies involve medical device types;
- Completed over 300 wound healing studies with a range of devices and study models;
- Conducted over 200 wound care clinical studies in conjunction with global regulatory support;
- Performed a wide variety and number of biological safety studies and over 200 customized preclinical studies on neurological devices;
- Performed 250 cardiovascular and 50 peripheral vascular projects in 30 countries with:
- 800 sites;
- 8,000 subjects;
- 5,000 monitoring visits;
- 450 databases built and managed.
About Endonovo Therapeutics Inc.
Endonovo Therapeutics is a commercial-stage developer of noninvasive wearable Electroceuticals® therapeutic devices for pain relief, general wellness and wound curatives. The Company's current portfolio of commercial and clinical-stage wearable Electroceuticals® therapeutic devices addresses wound healing, pain, post-surgical pain and edema, cardiovascular disease, chronic kidney disease, and central nervous system (CNS) disorders, including traumatic brain injury (TBI), acute concussions, post-concussion syndrome and multiple sclerosis. The Company's noninvasive Electroceutical® therapeutic device, SofPulse®, which uses pulsed short-wave radiofrequency at 27.12 MHz, has been FDA-cleared and CE marked for the palliative treatment of soft tissue injuries and post-operative pain and edema. It also has CMS national coverage for the treatment of chronic wounds. The Company's current portfolio of preclinical-stage Electroceuticals® therapeutic devices addresses chronic kidney disease, liver disease, non-alcoholic steatohepatitis (NASH), cardiovascular and peripheral artery disease (PAD), and ischemic stroke. The Company's noninvasive, wearable Electroceuticals® therapeutic devices work by restoring key electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing to occur.
Website: www.endonovo.com
Safe Harbor Statement
This press release contains information that constitutes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, trends, analysis, and other information contained in this press release including words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," and other similar expressions of opinion, constitute forward-looking statements. Any such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any future results described within the forward-looking statements. Risk factors that could contribute to such differences include those matters more fully disclosed in the Company's reports filed with the Securities and Exchange Commission. The forward-looking information provided herein represents the Company's estimates as of the date of the press release, and subsequent events and developments may cause the Company's estimates to change. The Company specifically disclaims any obligation to update the forward-looking information in the future. Therefore, this forward-looking information should not be relied upon as representing the Company's estimates of its future financial performance as of any date subsequent to the date of this press release.
Investor Relations Contact:
Endonovo Therapeutics, Inc.
Steve Barnes
800-701-1223 X108
sbarnes@endonovo.com
www.endonovo.com
