Medigus Expands Global Commercial Availability of MUSE™ Through Distribution Agreement With INNOVAMEDICA S.p.A. In Italy; New agreement broadens Medigus’ accessibility in key markets around the world

OMER, Israel, Nov. 22, 2016  -- Medigus Ltd. (MDGS) (MDGS), a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, today announced a distribution agreement in Italy with INNOVAMEDICA S.p.A, a privately owned distributor of minimally invasive medical devices. Under terms of the four-year agreement which will take effect January 1st 2017, INNOVAMEDICA S.p.A. will be required to purchase at least 1M € of Medigus Ultrasonic Surgical Endostapler (MUSE™) equipment over the course of the agreement.

“The Medigus MUSE system addresses a growing need in Italy by offering a patient-friendly solution for a widespread disorder such as GERD. We feel that our customers and their patients can greatly benefit from the use of this minimally invasive treatment option,” said Marco Cavalli, President, INNOVAMEDICA S.p.A.

 

“Medigus remains committed to achieving our near-term goals for 2016 and beyond, as evidenced by this new partnership in Italy, which is a key growth market for our organization,” said Chris Rowland, CEO of Medigus. “As MUSE continues to gain adoption and build its body of clinical data around the world, we are pleased to collaborate with esteemed partners such as INNOVAMEDICA to help provide healthcare communities with advanced technologies that enhance patient care and outcomes.”

 

The MUSE system is a single-use flexible transoral stapler that merges the latest advancements in microvisual, ultrasonic and surgical stapling. The device comes equipped with an ultrasonic sight and range finder and a micro ScoutCam™ CMOS camera, which enables a single physician to perform an incisionless transoral fundoplication — the procedure intended to treat the anatomical cause of gastroesophageal reflux disease (GERD).

 

GERD, commonly referred to as acid reflux, is largely characterized by heartburn. Those who experience symptoms such as heartburn or regurgitation twice a week or more, may be at risk for persistent GERD. According to a recent review study, approximately 12% of Italy’s population experience reflux on a weekly basis.

 

To learn more about Medigus and the MUSE system, please visit www.medigus.com.

 

About GERD

Gastroesophageal reflux disease (GERD) occurs when the lower esophageal sphincter spontaneously opens or does not properly close after use, allowing stomach acids to rise (or reflux) into the esophagus, which causes heartburn, irritation and potentially other discomforts. GERD affects approximately 81 million Americans each year, 8.6 million of whom experience severe symptoms.1 While some patients can attain symptom relief through the use of proton pump inhibitors, or PPIs, (acid reducing medications), there is growing concern around the prolonged use of PPIs, including increased risk of renal failure2, dementia3, bone fracture and interference with the adsorption of essential vitamins and minerals.4 A persistent state of untreated GERD may lead to Barrett’s esophagus, a precancerous condition which can progress to esophageal cancer. Patients who suffer from persistent GERD are seven times more likely to develop esophageal cancer.2

 

About The MUSE™ System

The MUSE™ system is a flexible transoral stapler that enables a minimally-invasive procedure for the long-term treatment of GERD. The device is fully integrated with latest technological advancements in microvisualization, ultrasound and surgical stapling, which allows a single physician or surgeon to perform anterior partial fundoplication more easily than with leading laparoscopic methods. Its intuitive endosurgical platform consists of a single use flexible surgical endostapler, equipped with a proprietary miniature camera, an ultrasonic sight and a range finder, and includes a handle with controls, an 80 cm flexible shaft, a 5 cm rigid section holding a cartridge with 5 standard 4.8mm titanium surgical staples, a ratchet controlled one-way articulating section, and a new, rounded distal tip for easier insertion. The MUSE system is FDA cleared and CE marked for the treatment of GERD and is reimbursable in the U.S. under Current Procedural Terminology (CPT®) code 43210 for Esophagogastric Fundoplasty Trans-Orifice Approach. CPT codes are descriptive terms physicians use for reporting all medical, surgical, and diagnostic services and procedures; Category I codes are most frequently used by healthcare providers when reporting a significant portion of their services. MUSE also has obtained the necessary licenses to market the product in Canada and Israel. For more information, visit www.RefluxHelp.com.

 

About INNOVAMEDICA S.p.A.

INNOVAMEDICA S.p.A. is an Italian private and independent trading company which has been operating in the medical sector since 1999 and is headquartered in Cusago, near Milan.

 

In Italy, it is a leading distributor of medical devices that are minimally invasive and enable mechanical surgery, especially in the fields of gynaecology, urogynaecology, enteral nutrition, digestive and bronchial endoscopy. 

 

INNOVAMEDICA S.p.A. sells medical devices that are not only technologically advanced, but also economically advantageous and affordable for the national health care system.

 

This press release may contain statements that are “Forward-Looking Statements,” which are based upon the current estimates, assumptions and expectations of the company’s management and its knowledge of the relevant market. The company has tried, where possible, to identify such information and statements by using words such as “anticipate,” “believe,” “envision,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate” and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words.  These forward-looking statements represent Medigus’ expectations or beliefs concerning future events, and it is possible that the results described in this news release will not be achieved. By their nature, Forward-Looking Statements involve known and unknown risks, uncertainties and other factors which may cause future results of the company’s activity to differ significantly from the content and implications of such statements. Among the factors which may cause the actual results to differ from the Forward-Looking Statements are changes in the target market and the introduction of competitive products, our ability to secure favorable reimbursement rates, regulatory, legislative and policy changes, and clinical results. Other risk factors affecting thecompany are discussed in detail in the Company's filings with the Securities and Exchange Commission. Forward-Looking Statements are pertinent only as of the date on which they are made, and the company undertakes no obligation to update or revise any Forward-Looking Statements, whether as a result of new information, future developments or otherwise. Neither the company nor its shareholders, officers and employees, shall be liable for any action and the results of any action taken by any person based on the information contained herein, including without limitation the purchase or sale of company securities. Nothing in this press release should be deemed to be medical or other advice of any kind.

 

MEDIA CONTACT: 

Chantal Beaudry/ Carrie Yamond

Lazar Partners Ltd.

212-867-1762

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INVESTOR RELATIONS (U.S.):

David Carey

Lazar Partners Ltd.

212-867-1768

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INVESTOR RELATIONS (Israel):

Iris Lubitch/ Noam Yellin

SmarTeam

972-3-6954333 

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1 Rubenstein JH & Taylor JB. (2010). Meta-analysis: the association of oesophageal adenocarcinoma with symptoms of gastro-oesophageal reflux. Alimentary Pharmacology & Therapeutics,32(10):1222-7. doi: 10.1111/j.1365-2036.2010.04471.x. Epub 2010 Sep 23.

2 Lazarus, B., Chen, Y., Wilson, F. P., Sang, Y., Chang, A. R., Coresh, J., & Grams, M. E. (2016). Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease.JAMA Internal Medicine JAMA Intern Med, 176(2). doi:10.1001/jamainternmed.2015.7193

3 Gomm, W., Holt, K. V., Thomé, F., Broich, K., Maier, W., Fink, A., . . . Haenisch, B. (2016). Association of Proton Pump Inhibitors With Risk of Dementia. JAMA Neurology JAMA Neurol, 73(4), 410. doi:10.1001/jamaneurol.2015.4791

4 Tetsuhide Ito, MD, PhD & Robert T. Jensen, MD (2010). Association of Long-term Proton Pump Inhibitor Therapy with Bone Fractures and effects on Absorption of Calcium, Vitamin B12, Iron, and Magnesium. Current Gastroenterology Reports, 12(6): 448–457. doi:  10.1007/s11894-010-0141-0