Endonovo’s SofPulse® Nears Final Stages to Receive Taiwan FDA License to Distribute in Taiwan

Rhea-AI Summary

Endonovo Therapeutics, Inc. (OTCQB: ENDV) announced progress in obtaining Taiwan FDA approval for its flagship product, SofPulse^®, designed for pain management and recovery after surgery. This non-invasive device uses Pulsed Electro-Magnetic Field (PEMF) therapy to aid healing and reduce edema. Partnering with Evermed Medical Enterprises Co., a Taiwanese distributor, Endonovo aims to leverage Evermed's extensive network in Taiwan's healthcare market. Despite experiencing delays, the company is nearing final clearance and anticipates a positive reception for SofPulse^® in Taiwan, backed by strong clinical feedback and U.S. FDA certification.

Positive

• Entering final stages of obtaining Taiwan FDA license for SofPulse^®.
• Partnership with Evermed enhances market entry capabilities in Taiwan.
• SofPulse^® has received positive clinical feedback, indicating strong potential for market acceptance.
• Product offers a non-opioid pain management solution, aligning with healthcare trends.

Negative

• Delays in obtaining Taiwan FDA approval may hinder market entry timeline.

Los Angeles, CA, March 23, 2023 (GLOBE NEWSWIRE) -- Endonovo Therapeutics, Inc. (OTCQB: ENDV) -- a medical device company known for its innovative and effective pain management solutions -- announced today that it is entering the final stages of clearance to receive a Taiwan FDA (TFDA) License for Medical Devices to distribute its flagship product, SofPulse^® in Taiwan.

Sofpulse^® medical devices are designed to accelerate recovery and reduce pain and edema post operatively. SofPulse^® technology uses a non-invasive Pulsed Electro-Magnetic Field (PEMF) therapy that uses low-frequency electromagnetic fields to stimulate the body's natural healing processes, stimulate circulation and speed up the healing process.

With its launch in Taiwan on the horizon, Sofpulse^® is poised to help more patients experience the benefits of this revolutionary technology.

SofPulse^® Partners with Taiwan Distributor Evermed Medical Enterprises Co.

Evermed is a Taiwanese medical device distributor that provides a wide range of medical products and services to hospitals, clinics and healthcare professionals. Established in 2012, Evermed has an extensive network of contacts throughout the Taiwanese surgical market and is known for its expertise in medical device distribution.

Ira Weisberg, President of Endonovo’s Medical Division, said: "We are proud to partner with Evermed to bring the SofPulse^® device to Taiwan, a market known for its focus on patient care and medical innovation. Our global mission is to provide healthcare professionals with the best tools possible to help patients recover quickly and effectively. We are confident that Evermed's expertise and network in the Taiwanese market will make a significant impact on the health and well-being of patients in the region.”

Evermed’s Chief Executive Officer, George Wang, commented: “Evermed feels that the SofPulse^® device with its proven results in successfully reducing pain and edema in surgical operations is the best product to offer our Taiwanese distribution network. We are excited to partner with Endonovo to introduce SofPulse^®-- a proven drug-free, postoperative pain and edema reduction device -- to the Taiwanese surgical market.”

Evermed Taiwanese Medical Device Distributor

Evermed is a medical device distributor that specializes in introducing innovative surgical devices that have proven efficacy and have shown to assist in positive patient outcomes in surgical care. The company has established relationships across all surgical specialties, which helps to set them apart from other companies in the Taiwanese medical device market.

"Our sales and distribution offices and teams are strategically located throughout Taiwan, which allows us to effectively service Taiwan's 23 million population, hospitals and medical centers. We are confident that the SofPulse^® device will be well received by healthcare professionals and patients alike, and we look forward to helping improve patient outcomes in Taiwan," Wang concluded.

SofPulse^® to Launch Revolutionary Pain Management Device in Taiwan in 2023

SofPulse^® patented technology is designed to provide safe and effective alternative to opioid pain management for surgical patients. “As we continue to navigate the global health crisis, it is essential to prioritize patient-centered solutions that can improve health outcomes and reduce healthcare costs,” Weisberg pointed out.

While there have been delays throughout the process in obtaining clearance for SofPulse^® medical device in Taiwan, Evermed and Endonovo remained unwavering in their determination to bring their innovative technology to patients in need. With newly obtained U.S. State Department certification of Certificate of Foreign Government (CFG) distribution, final Taiwan FDA approval for medical device license is months away from obtaining final distribution license for its medical market.

“Our commitment to patient care and dedication to improving outcomes is unwavering, and we're confident that this groundbreaking technology will change the game when it comes to pain management and post-surgical recovery. The positive feedback we've received from clinical trials and healthcare professionals is overwhelming, and we can't wait to see the impact our device will have on patients' quality of life in Taiwan,” Weisberg commented.

SofPulse^® to Improve Surgical Outcomes in Taiwan

Clinical studies have demonstrated that SofPulse^® helps reduce pain and edema (swelling), promote bone and soft tissue repair and decrease the need for opioids and other pain medications. Once cleared for distribution in Taiwan, SofPulse^® is poised to provide healthcare professionals with the tools they need to improve patient care and outcomes.

"We are so close to receiving the rights to distribute the SofPulse^® device in Taiwan. This technology has already received certification from the U.S. FDA and has the potential to provide safe, effective and affordable solutions for patients in Taiwan and beyond," Weisberg concluded.

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 construction industry.

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 Endonovo Therapeutics' partnership with Evermed?

The partnership with Evermed is crucial for Endonovo as it enables access to a vast distribution network in Taiwan, facilitating the launch of SofPulse^® in the Taiwanese market.

What is the current status of SofPulse^® FDA approval in Taiwan?

Endonovo is in the final stages of obtaining Taiwan FDA approval for SofPulse^®, with expectations for clearance in the coming months.

How does SofPulse^® aid in pain management?

SofPulse^® uses non-invasive Pulsed Electro-Magnetic Field (PEMF) therapy to stimulate healing and reduce pain and edema post-surgery.

When is SofPulse^® expected to launch in Taiwan?

Endonovo anticipates launching SofPulse^® in Taiwan once final FDA approval is secured, likely in the near future.

What is the market potential for SofPulse^® in Taiwan?

Given Evermed's established network and the increasing focus on patient-centered solutions, SofPulse^® has strong market potential in Taiwan.