Tag Archives: Medical Device

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Origami and citoQualis will work together to help Medical Device startups get products to global markets faster

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KFAR SABA, Israel, 9-Nov-2021 — /EPR HEALTHCARE NEWS/ — Origami, a leading provider of no-code business process automation software for Medical Device and other industries, and citoQualis, a regulatory and business advisory leader for EU Medical Device companies, are announcing a partnership to help Medical Device startups get products to global markets faster.

Medical Device startups face unique pressures due to numerous country-specific regulations. This new partnership will help companies efficiently manage their regulatory approval processes, and enable rapid business growth.

Origami’s medical device customers operate around the world. With recent EU regulatory updates, companies are seeking strategic regulatory and business guidance to help them get and maintain product approval in that geography. The new partnership will provide Origami customers with access to citoQualis expertise in business and complex regulatory landscapes.

The citoQualis team points out that Medical Device startups have global workforces that “expect to access their systems from wherever they’re located, and to use those systems to collaborate internally and with citoQualis” says Mr. Wolfgang Werner, CEO of citoQualis.

According to Mr. Werner, “As advisors, it’s our job to identify opportunities and share our insights. For startups, the faster a product moves from idea to production, the better. With Origami’s flexibility, we are able to give our clients a software option that works for them now and as they scale.”

Germany and other EU countries have strong medical device startup ecosystems, which citoQualis is well connected to. Origami is excited to work with citoQualis and the startups they advise, noting how both companies focus their solutions and teams on helping customers succeed in complex environments.

Yaniv Shimony, CEO of Origami says “startup CEOs recognize Origami’s business value, in that they always have the solution their company needs. When you create a new and innovative medical device, using inflexible software point solutions slows your business down. With Origami, information is instantly available about any part of your business such as sales, quality, design, product approvals, manufacturing, equipment maintenance, purchasing, supplier compliance, invoicing, complaints and more.”

Existing customers will be able to maintain and expand EU market access by working with local regulatory experts, facilitating hundreds of millions of Euros of revenue.

SOURCE: EuropaWire

Healthcare, Healthcare Products, Healthcare Services, Healthcare Solutions

CoapTech Raises $7 Million in Series B Funding Led by Hunniwell Lake Ventures

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Baltimore, MD, 2020-Aug-28 — /EPR HEALTHCARE NEWS/ — CoapTech LLC (Baltimore, MD), a leading medical device start-up pioneering the world’s first and only ultrasound-based feeding tube placement system, announced today the closing of a Series B investment of $7 million led by Palo Alto-based medical device venture capital firm Hunniwell Lake Ventures. The financing will be used to fund CoapTech’s commercialization of its FDA-cleared PUMA-G System.

By simplifying gastrostomy procedures to the point where they can be conducted at the patient’s bedside with ultrasound, hospitals using PUMA-G benefit by freeing up surgical suites and personnel resources for COVID and other clinical priorities, minimizing cross-contamination, and improving efficiencies in care.

CoapTech was founded by critical care physician Dr. Steven Tropello and clinical innovation researcher Howard Carolan, to reduce unnecessary delays, harm, and costs for feeding tube placement, a vital therapy for millions of patients each year around the world.

Howard Carolan, CEO and Co-Founder, states: “We have been receiving fantastic feedback from hospitals in our initial launch program, which are using the PUMA-G System to revolutionize feeding tube placement. By using ultrasound at the patient bedside, rather than the conventional approach of orchestrating expensive and inefficient consults, critical care physicians are completing these procedures in minutes, on the same shift a feeding tube is first indicated. We’re seeing early indications those efficiencies result in patients leaving the ICU sooner, which saves hospitals many thousands of dollars per admission. A substantial portion of this new funding is from physicians who have seen the device and believe it can become the new default method for feeding tube placement.”

Dr. Steven Tropello elaborates, “the PUMA-G System is proving itself ready for standard-of-care adoption for safe and timely gastrostomy tube placement. It is also proving a powerful approach in the fight against COVID, by completely eliminating transport of patients, team members, and reprocessed tools throughout the hospital in favor of a sterile, disposable, bedside solution. I am also very excited about other clinical applications of the PUMA platform we are developing and aim to have for patients in the near future.”

This Series B investment was led by Hunniwell Lake Ventures, a Palo Alto-based medical device venture capital firm.

Daniel Teo, Managing Partner at Hunniwell Lake Ventures, further states “Coaptech’s PUMA System has the potential to transform gastrostomy and many other surgical procedures by allowing them to be performed using ultrasound at the bedside, in hospitals, ambulatory centers, skilled nursing facilities, and LTACHs (Long-term Acute Care Hospitals). This also benefits patients by bringing the procedure closer to the Point-of-Demand (PoD) and giving them more options with a larger community of medical providers capable of performing the procedure.

Via EPR Network
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First Rhenium-SCT® (Skin Cancer Therapy) treatment in Germany done by Dr. Lutz-Hendrik Holle

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HANAU, Germany, 4-Oct-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta®, a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today, that Dr. Lutz-Hendrik Holle, Medical Director of the interregional professional association for nuclear medicine in Hanau, has accomplished the first Rhenium-SCT® (Skin Cancer Therapy) treatment in Germany. This state-of-the-art technology of local radionuclide therapy offers a painless and non-invasive treatment option for patients with basal cell carcinoma and squamous cell carcinoma (BCC and SCC) and the interregional professional association for nuclear medicine Hanau is the first center in Germany that offers the Rhenium-SCT®.

With approximately 50.000 outpatient examinations annually, the interregional professional association for nuclear medicine Hanau is one of the biggest nuclear medicine service providers in Hesse. The offered services include a variety of different modern treatment and diagnostic methods. The key argument for the expansion of the spectrum was that the Rhenium-SCT® is a new, painless and highly efficient treatment option that also delivers excellent cosmetic results. Besides being a painless alternative to other procedures, the Rhenium-SCT® also allows the treatment of numerous NMSC lesions consecutively in a single session, which was already realized during the first treatment in Hanau. This has also attracted international attention so that an American patient travelled to Hanau for the treatment.

“This therapy is particularly suitable for tumor localizations where good cosmetic results are to be achieved. The fact that the treatment is completely painless and can be performed in just one session is a great advantage”, says Dr. Lutz-Hendrik Holle, Medical Director of Nuclear Medicine in Hanau.

“We are very happy and proud to be able to offer our revolutionary treatment to patients in Germany now. The interregional professional association of nuclear medicine in Hanau is an excellent partner for NMSC patients in the fight against NMSC”, said Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “Unfortunately, Germany is one of the countries that has experienced a drastic increase in newly diagnosed NMSC cases in recent years. Our highly qualified team strives to provide physicians and patients with a non-invasive and affordable solution to treat NMSC, while focusing on the needs of the patient.”

The global incidence of non-melanoma skin cancers has been drastically increasing over the past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. In certain analyzed areas of Germany there was an increase in the incidence between the year 2005 and the year 2014 by about 30%1. To serve the increasing medical need for innovative therapies in this field and to improve the quality of patients’ lives, OncoBeta® GmbH has developed its innovative Rhenium-SCT® which only require a single application in most of the cases, applied in one single session with excellent aesthetic outcomes.

Via EPR Network
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2019 Red Herring North America Top 100 Winner: New recognition of OncoBeta’s success in developing and providing an innovative therapy for non-melanoma skin cancer patients

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Pasadena, CA, U.S.A., 6-Jul-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta®, a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today, that it was honored as a Red Herring Top 100 North America Award winner recognizing the continent’s most exciting and innovative private technology companies. After being recognized with the Red Herring Top 100 Europe Award earlier this year, this is now the second recognition obtained by Red Herring.

The winners, celebrated at a special awards ceremony at the Westin Pasadena hotel, have been chosen from thousands of entrants, whittled down to hundreds making the trip to California. The ceremony, led by Red Herring chairman Alex Vieux, was preceded by two days of keynote speeches, discussions and finalist presentations.

Companies were judged by industry experts, insiders and journalists on a wide variety of criteria including financial performance, innovation, business strategy, and market penetration. Winners ran the gamut of verticals, from FinTech and Marketing to Security, IoT, and many more industries.

Red Herring’s editors have been evaluating the world’s startups and tech companies for over two decades. It gives them the ability to see through the industry’s hype to pick firms that will continue on a trajectory to success. Brands such as Alibaba, Google, Kakao, Skype, Spotify, Twitter and YouTube have all been singled out in Red Herring’s storied history.

“2019’s crop of Top 100 winners has been among our most intriguing yet,” said Vieux. “North America has led the way in tech for so many years, and to see such unique, pioneering entrepreneurs and companies here in California, which is in many ways the heartland of the industry, has been a thrilling experience.”

“What has excited me most is to see so many people forging niches in high-tech and cutting edge sectors,” added Vieux. “Some of the technical wizardry and first-rate business models showcased here at the conference has been fantastic to learn about. We believe OncoBeta® embodies the drive, skill and passion on which tech thrives. OncoBeta® should be proud of its achievement – the competition was incredibly strong.”

“Being named as one of the Red Herring’s Top 100 North America award winner in addition to the Top 100 Europe is a great honor for us.” states Shannon D. Brown III, CEO of OncoBeta®. “The spirit of the award aligns perfectly with our team’s mission in the fight against non-melanocytic skin cancer (NMSC) with the Rhenium-SCT®.”

The complete list of the 2019 Red Herring North America Top 100 Winners can be found here in alphabetical order: https://www.redherring.com/2019-rhna-top100-winners/

Red Herring’s press release is available online at https://www.redherring.com/red-herring-2019-top-100-north-america-winners-press-release/

SOURCE: EuropaWire

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Sway Medical’s app for sports concussion exam received European CE Mark as Medical Device

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sway-concussiontest-is-a-validated-ios-app-based-concussion-management-system

TULSA, OK, 08-Sep-2016 — /EPR HEALTHCARE NEWS/ — Sway Medical is a US medical device company who’s software turns an iPhone or iPad into a mobile medical device that provides immediate medical grade, objective concussion measurement to medical professionals.

Sway Medical LLC (Sway) would like to announce its official availability in all European Union Countries. Sway was issued its CE Mark after being marketed in the United States and Canada for two years. This is significant because European sports organizations ranging from youth through pro level now have an affordable and convenient sideline assessment tool supporting concussion related medical decision making. Medical professionals and trained coaches can obtain a concussion assessment via an Apple mobile device (iPhone or iPad) and the Sway Balanceâ„¢ System web-portal. Acute objective measurements are obtained by performing a 1.5 minute balance and reaction time test protocol. Licensed athletic trainers, physical therapists and athletic therapists are able to join physicians in acutely managing the underserved market of youth sports, ages six and older.

Concussion injuries are very common in sports, often going un-reported or ignored until the obvious symptoms have incapacitated the athlete or draws the attention of a parent or coach. Second Impact Syndrome (SIS) is a serious medical condition with published mortality rates of up to 50%. SIS occurs when an athlete returns to play while still recovering from an initial concussion injury. During this time, the brain is highly susceptible to additional injury and complications. The Sway Balance™ System is able to accurately assess and track the acute and chronic outcome related to an athlete’s balance, motion reaction time and concussion symptoms. The Sway Balance™ System provides a graphical representation comparing suspicious injury event tests against a pre-injury “normative” or baseline score. The comparison of event tests against an established baseline is a common measurement for traumatic brain injury diagnosis and recovery tracking.

The Sway Balance™ System is available for purchase by licensed medical professionals involved in school, occupational or sports medicine through www.swaymedical.com. Additional protocols are available to assess an individual’s “Fall Risk” or “Functional Status”.

SOURCE: EuropaWire