Endonovo's SofPulse® Secures Taiwan FDA Approval

Rhea-AI Summary

Endonovo Therapeutics receives regulatory approval for SofPulse® in Taiwan

Positive

• Full regulatory approval of SofPulse® by the Taiwan Food and Drug Administration (TFDA)

Negative

• None.

Los Angeles, CA, Oct. 12, 2023 (GLOBE NEWSWIRE) -- Endonovo Therapeutics, Inc. (OTCQB: ENDV) US-based medical device company, today announced the full regulatory approval of its flagship product, SofPulse^® by the Taiwan Food and Drug Administration (TFDA), the regulatory division of the Ministry of Health and Welfare (MOHW).

The approval is a significant accomplishment in introducing innovative Pulsed Electro Magnetic Field (PEMF) technology into the Taiwanese surgical market through Endonovo's valued distribution partner, EverMed Medical Enterprises Co..

George Wang, CEO of EverMed, said: “TFDA approval of SofPulse^® is a significant advancement for healthcare in Taiwan and strengthens our product portfolio. Our rigorous evaluations and clinical assessments have consistently highlighted the unique benefits and advantages of SofPulse^® PEMF medical devices in assisting surgical recovery, inflammation reduction and post-operative non-opioid pain management. We envision a profound positive impact on the well-being of countless patients undergoing surgical procedures annually in Taiwan.”

Taiwan's Surgical Market Potential

Taiwan, with a population exceeding 23 million, sees approximately 4.6 million major surgeries annually. EverMed has identified more than 1.5 million surgical cases that would benefit most from SofPulse^® PEMF technology.

The SofPulse^® TFDA approval marks the initial phase of Endonovo's expansion, through EverMed, into the largely untapped PEMF and surgical sectors in Taiwan. Initial sales efforts will focus on introducing SofPulse^® into multiple Taiwanese hospital surgical markets. EverMed will target four surgical specialties -- including cardiovascular surgery, orthopedic surgery, spinal surgery and plastic surgery -- representing hundreds of thousands of surgical cases.

Ira Weisberg, President of Endonovo's SofPulse^® division, stated: "We are eager to collaborate with EverMed to expand SofPulse^® use throughout Taiwan. We consider EverMed and its sales and marketing team to be the ideal partners for our venture into Taiwan's surgical markets. The establishment of an international distribution agreement in Taiwan, with helps us establish Endonovo’s willingness to expand globally into new regions increasing brand awareness internationally.

Incorporation into Taiwan's National Health Insurance

EverMed's strategic partnership distributing SofPulse^® extends beyond the immediate sales and marketing push and includes overseeing the regulatory aspects. Plans are to enable SofPulse® to be incorporated into Taiwan's National Healthcare Insurance (NHI) system.

EverMed will oversee SofPulse^® medical device registration within Taiwan's NHI program and the development of billing codes for its use in all hospitals and medical facilities throughout the country. The Taiwan NHI, initiated in 1995, offers healthcare coverage to every Taiwanese citizen, encompassing medical and surgical procedures. NHI processing also involves defining market positioning and pricing within the entire Taiwanese medical system. EverMed will administer NHI registration, branding, marketing and SofPulse^® commercialization efforts across Taiwan.

SofPulse^® Commercialization in Taiwan

EverMed and Endonovo’s commercialization of SofPulse^® in Taiwan commences with product registration with the NHI. This will be followed by an extensive sales and marketing campaign to introduce surgeons and patients to the benefits of PEMF therapy. Sales and marketing strategies include leveraging existing connections with MD’s, surgeons, hospitals and medical facilities to promote the expansion of surgical applications across Taiwan's three regions.

As healthcare professionals and patients experience the tangible benefits of PEMF technology in post-operative care, SofPulse^® is poised for success and wide acceptance throughout the Taiwanese surgical market.

EverMed’s Wang added: “As surgeons and medical professionals perform more cases, SofPulse^® has shown to help patients recover faster, use less opioid pain management drugs, and return to their normal lives faster. This exciting development empowers us to reduce the dependency on conventional opioid pain medications for a wide range of patients. We eagerly anticipate overseeing the introduction and widespread use of SofPulse^® with Endonovo throughout Taiwan."

Taiwan FDA Process and International Expansion

The TFDA is the regulatory arm of Taiwan’s MOHW and is considered the driving force behind healthcare improvement in Taiwan. MOHW's focus is on promoting the health and well-being of all citizens in Taiwan by improving healthcare quality, advancing technological development, ensuring quality, efficiency, resource allocation contributing to international affairs.

SofPulse^® TFDA approval helps to validate Endonovo’s innovative approach to pain relief and non-opioid alternatives that has garnered widespread attention in the ever-growing global medical markets.

The establishment of an international distribution agreement in Taiwan, with EverMed helps establish Endonovo’s willingness to expand globally into new regions increasing brand awareness internationally.

About Endonovo Therapeutics, Inc.

Endonovo Therapeutics is currently structured into two divisions: Legacy – a commercial-stage developer primarily of noninvasive wearable Electroceuticals^® therapeutic devices for pain relief, general wellness and wound curatives with many of its products marketed under the SofPulse^® brand name; and its Build Up Strategy – acquiring complementary specialty service providers in the medical technology and construction industries.

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 Ext. 108
sbarnes@endonovo.com
www.endonovo.com

Media Contact:
Gregory A. McAndrews
Greg McAndrews & Associates
(310) 804-7037
greg@gregmcandrews.com

FAQ

What is the significance of TFDA approval for SofPulse®?

The TFDA approval is a significant accomplishment for Endonovo Therapeutics as it allows them to introduce their innovative PEMF technology into the Taiwanese surgical market.

What is the potential market for SofPulse® in Taiwan?

Taiwan sees approximately 4.6 million major surgeries annually, and EverMed has identified over 1.5 million surgical cases that would benefit from SofPulse® PEMF technology.

What surgical specialties will EverMed target?

EverMed will target four surgical specialties in Taiwan, including cardiovascular surgery, orthopedic surgery, spinal surgery, and plastic surgery.

What are the plans for SofPulse® in Taiwan's National Health Insurance (NHI) system?

EverMed will oversee SofPulse® medical device registration within Taiwan's NHI program and the development of billing codes for its use in all hospitals and medical facilities throughout the country.

How will SofPulse® be commercialized in Taiwan?

The commercialization of SofPulse® in Taiwan will begin with product registration with the NHI, followed by an extensive sales and marketing campaign.

What is the role of the TFDA in Taiwan's healthcare improvement?

The TFDA is the regulatory arm of Taiwan's Ministry of Health and Welfare (MOHW) and plays a crucial role in promoting healthcare improvement in Taiwan.

What impact does the TFDA approval have on Endonovo's international expansion?

The TFDA approval helps validate Endonovo's innovative approach to pain relief and non-opioid alternatives, which contributes to their international brand awareness and expansion.