Tag Archives: nervous disorders

Germany’s Largest Authorized Health Insurance Company Approves MyoPro | Business | Instant News


BOSTON – (BUSINESS WIRE) – February 16, 2021–

Myomo, Inc. (NYSE American: MYO) (“Myomo” or “Company”), a wearable medical robotics company offering enhanced functionality for those with neurological disorders and upper limb paralysis, today announced Techniker Krankenkasse (TK), Germany’s largest Statutory Health Insurance (SHI) company. , now approves MyoPro replacement on a case by case basis. TK covers more than 10 Million lives insured and joins the ranks of other major German health insurance providers including BARMER, IKK Classic, regional AOK insurance and several BKK insurances which collectively cover 28 million German lives and have now approved funding for MyoPro.

About 90% of the German population is covered by SHI providers.

In addition, one of the largest private health insurance companies in Germany, Allianz, has now authorized MyoPro. Private insurance covers about 9% of the population.

Myomo’s Managing Director for Europe, John Frijters, stated, “Many users who have received MyoPro through German insurance experience loss of hand and arm function due to stroke, brachial plexus injury or spinal cord injury. Receiving MyoPro as a result of this insurance decision changed their life. “

In Germany, MyoPro is administered through a growing network of Orthotic and Prosthetic (O&P) clinics across the country. Currently, these 35 facilities serve and support MyoPro users.

Paul R. Gudonis, CEO of Myomo, said, “Our progress in Germany, although now limited by the COVID-19 lockdown, shows us that there is strong and wide-ranging demand for MyoPro. Coupled with the joint venture we recently announced in China, we are working to become the global standard of care for those with paralyzed or weak arms. “

This announcement coincides with the introduction of the new Myomo website in German. These can be found on www.myomo.de.

Myomo, Inc. is a medical robotics company that offers enhanced arm and hand function to those with neurological disorders and upper limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper limb orthosis designed to support the arm and restore the function of a weakened or paralyzed arm of a patient who has had a CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS or other neuromuscular disease or injury. It is currently the only device on the market that, by sensing a patient’s own EMG signal via a non-invasive sensor in the arm, can restore an individual’s ability to perform daily activities, including self-feeding, carrying objects and performing household tasks. Many are able to return to work, live independently, and reduce maintenance costs. Myomo is headquartered in Cambridge, Massachusetts, with sales and clinical professionals throughout the US and international representatives. For more information, please visit www.myomo.com.

Forward-looking Statements

This press release contains forward-looking statements regarding the Company’s future business expectations, including the benefits expected from insurance coverage in Germany and our activities in Germany, Australia and China, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forwards are only predictions and may differ materially from actual results due to various factors.

These factors include:

  • our sales and commercialization efforts;
  • our ability to obtain reimbursements from third party payers for our products;
  • our reliance on external sources to finance our operations, to the extent that we do not break even in cash flows;
  • our ability to effectively execute our business plans and improve our operations;
  • our expectations for our development program; and
  • general market, economic, environmental and social factors, including the ongoing COVID-19 pandemic, which may affect the evaluation, installation, delivery and sale of our products to patients.

Further information on these and other factors that could potentially affect our financial results including in Myomo’s filings with the Securities and Exchange Commission, including those contained in the risk factors section of the Company’s annual report on Form 10-K, quarterly reports on Form 10 -Q and other submissions with the Commission. The company warns readers not to rely too much on forward-looking statements, which only take effect on the date they are made. Although the forward-looking statements in this release of financial information are based on our beliefs, assumptions and expectations, taking into account all the information currently available to us, we cannot guarantee future transactions, results, performance, achievements or results. No guarantee can be made for any investor by anyone that the expectations reflected in our forward-looking statements will be achieved, or that deviations from them will be material and detrimental. The Company disclaims any further obligation to revise forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of events that were anticipated or unexpected.

212-838-3777 Public Relations:

KEY WORDS: MASSACHUSETTS GERMANY EUROPE NORTH AMERICA

INDUSTRIAL KEYWORDS: PROFESSIONAL SERVICES HEALTH THERAPY PHYSICAL BIOTECHNOLOGY HEALTH ASSURANCE

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PUB: 02/16/2021 08:30 AM / DISC: 02/16/2021 08:30

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Novaremed Receives US $ 50 Million Capital Commitment from Global Emerging Markets | Business | Instant News


BASEL, Switzerland – (BUSINESS WIRE) – 28 Jan 2021–

Novaremed AG (Novaremed), a clinical stage Swiss biopharmaceutical company, today announced that it has signed an agreement with GEM Global Yield LLC SCS (GEM), a private alternative investment group based in Luxembourg with a capital commitment of US $ 50 million.

Under the agreement, GEM committed to provide Novaremed a share subscription facility of up to US $ 50 million for a period of 36 months following the public listing of the company’s shares. Novaremed will control the time and maximum amount of withdrawals under this facility and have no minimum withdrawal obligations. Along with the public listing of Novaremed’s shares, the company will issue a warrant to GEM to purchase Novaremed’s shares.

Depending on available funding, the proceeds from this financing will be used to advance the clinical development of Novaremed’s flagship product, NRD135S.E1, a researched small molecule non-opioid drug for the treatment of painful diabetic peripheral neuropathy (PDPN).

“We are very pleased with this financial arrangement with GEM,” said Isaac Kobrin, MD, Executive Chair of the Novaremed Council. “This funding agreement with GEM will help us, following the company’s public listing, to advance our highly innovative core product that we are developing for the non-opioid treatment of patients with diabetes-related chronic neuropathic pain. The ongoing opioid crisis has raised a high unmet medical need for new treatments that can control chronic pain without causing addiction, dependence, and abuse. “

About Painful Diabetic Peripheral Neuropathy (PDPN)

Injury to peripheral nerves of various etiologies (eg, diabetic peripheral neuropathy, postherpetic neuralgia, neuropathy due to cancer or trauma) can cause chronic, intractable, severe neuropathic pain. PDPN is one of the most common complications of diabetes. Up to 20% of patients with PDPN experience chronic and debilitating neuropathic pain that substantially impairs quality of life. Many of the drugs currently available for the treatment of PDPN have limited efficacy and are often not well tolerated due to a variety of side effects, including side effects on the central nervous system.

The rapidly increasing prevalence of diabetes and PDPN and the limited availability of available therapies make PDPN treatment a condition of unmet medical needs.

NRD135S.E1 (or NRD.E1) is a new chemical entity, which is available orally and is being developed for the treatment of PDPN. The mechanism of action of NRD.E1 differs from approved pain therapies because the drug studied does not bind or interact with pain-related receptors nor does it bind to opioid receptors.

The complete clinical study with NRD.E1 includes three Phase I studies (single and multiple dose rise studies and dietary effects studies). The Proof of Concept Phase IIa study (ClinicalTrials.gov Identifier: NCT02345291) is a 3-week, dose finding, placebo-controlled, randomized, multi-center study. The study was conducted on 88 patients with moderate to severe PDPN and compared three doses (10 mg, 40 mg and 150 mg / day) of NRD.E1 with a placebo. Study results suggest clinically relevant dose-related pain reduction; NRD.E1 was well tolerated at all tested doses.

Novaremed has an open IND for NRD.E1 to conduct a 12-week Phase II study on 120 patients with moderate to severe PDPN in the US. This study compared the efficacy, safety, and tolerability of a single dose of NRD.E1 with a placebo. The main aim of this study was to demonstrate that NRD.E1 was superior to placebo in reducing neuropathic pain associated with PDPN. The primary end point was the change from baseline to Week 12 in the weekly daily pain mean, as measured by the 11-point Numeric Rating Scale (NRS). The main secondary objectives of this study were to evaluate (i) the safety and tolerability of NRD.E1, (ii) the presence of withdrawal symptoms after sudden drug withdrawal, and (iii) the effect of NRD.E1 on insomnia and quality-of-life indicators.

In December 2020, the US Food and Drug Administration (FDA) granted NRD.E1 a Fast Track Designation for the treatment of PDPN.

Novaremed Ltd, a wholly owned subsidiary of Novaremed AG was founded in 2008 in Israel and Novaremed AG was founded in 2017 in Switzerland. Novaremed aims to be a leader in the discovery and development of innovative treatment options for chronic pain and is currently developing NRD.E1, a small molecule of non-opioid active orally with a new mechanism of action for the treatment of PDPN.

Global Emerging Markets (“GEM”) is a $ 3.4 billion alternative investment group with operations in Paris, New York and Los Angeles. GEM manages a variety of investment platforms focused on emerging markets and has completed more than 400 transactions in 70 countries. Each investment vehicle has a different level of operational control, risk-adjusted returns, and a different liquidity profile. The group of funds and investment vehicles provides GEM and its partners with exposure to: Small-Medium Cap Management Purchases, Private Investments in Public Equities and certain venture investments. For more information: www.gemny.com

CONTACT: For more information about Novaremed, please contact:

Executive Chair of the Council

KEY WORDS: SWISS EUROPE

INDUSTRY KEYWORDS: HEALTH DIABETES OTHER CLINICAL TESTS OF HEALTH BIOTECHNOLOGY

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PUB: 01/28/2021 08:45 AM / DISC: 01/28/2021 08:45

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