New Cures Act regulations establish API-based integration to overcome COVID-19 pandemic impacts

Cision PR Newswire | July 29, 2020

Unlocking value from the data scattered across healthcare communities was once a tantalizing opportunity. After COVID-19, it is an existential necessity. Chilmark Research's latest Market Trends Report, Open APIs in Healthcare: The Future of Data Integration, captures a market whose approach to data access and integration will be changing substantially in the coming years and introduces a subvertical within healthcare IT that anticipates a 16% CAGR through 2025.Outside healthcare, the ascendance of data access and integration facilitated by application programming interfaces (APIs) is the culmination of decades of technology evolution and implementation lessons with distributed applications. Across the SaaS landscape in particular, APIs have become the preferred method for accessing data and conducting transactions across applications and organizations. Developers recognize and appreciate the value of loosely coupling their applications and data, wherever each is located.

Spotlight

Based on a recent HIMSS Analytics survey, this paper reveals results that can help providers assess their progress and compare it to that of other providers, offering an idea of how to better identify and address chinks in the organization's armor.


Other News
HEALTHTECH SECURITY

Tivic Health to Acquire Assets of Reliefband

Tivic Health | October 18, 2022

Tivic Health® Systems, Inc. a commercial-phase health technology company focused on bioelectronic medicine, announced it has entered into a definitive agreement to acquire the Reliefband product line for nausea treatment and all related assets from Reliefband Technologies, LLC. Reliefband has been an innovator in wearable, FDA-cleared electronic therapeutics for treatment of nausea and vomiting. Reliefband has multiple products available both over-the-counter and by prescription. “We are incredibly excited to add the full suite of Reliefband products to our commercial portfolio. The Reliefband team successfully pioneered a direct-to-consumer business model for medical products. This acquisition, when combined with our growing direct-to-consumer sales of ClearUP, will significantly accelerate Tivic’s revenue opportunities.” Jennifer Ernst, CEO of Tivic Health Recurring nausea impacts approximately 1 in 6 US adults. According to QY Research, nausea treatment is a $2.4B market in the US and $5.5B globally, growing at 6.5% CAGR. Reliefband’s wrist-worn electronic nerve stimulators have been FDA-cleared for treatment of nausea associated with seven independent clinical indications, including nausea from motion sickness, pregnancy, migraines, anxiety, chemotherapy, various medications and hangovers. The patented products are backed by 40 peer-reviewed clinical studies and have generated over 3500 Amazon reviews averaging 4+ stars. Both Reliefband and ClearUP products offer consumers ways to manage health-related conditions without the issues and side effects often associated with medication use. Both are FDA-cleared, highly effective, fast-acting, convenient, and drug-free. Both currently are sold primarily online, and both have received CE Marks allowing international expansion. In addition to the Reliefband direct-to-consumer branded products, Tivic will also acquire Reliefband’s Reletex-branded prescription nausea treatments. Reletex products are currently distributed by hospitals and medical professionals and are reimbursed under HCPCS code E0765 for certain conditions. “We look forward to growing Tivic with the addition of clinically proven, revenue-producing bioelectronic products that have seen strong customer adoption and growth,” continued Ernst. Consideration to be provided by Tivic consists of up to $33.5 million, of which up to $1.5 million can be paid, at the election of Tivic, in restricted common stock of Tivic. Consideration is subject to working capital adjustments, less Reliefband transaction expenses and any indebtedness of Reliefband at closing. The transaction is expected to be consummated in the fourth quarter of 2022 or first quarter of 2023 after the satisfaction of certain customary closing conditions, including but not limited to securing the financing necessary to pay the purchase price. Additional information on the transaction can be found in a Current Report on Form 8-K filed by Tivic with the Securities and Exchange Commission (SEC).

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HEALTH TECHNOLOGY

IMPLANET Signs an Exclusive Distribution Contract for SMTP Technology Co.’s Ultrasonic Surgical Scalpel in France

IMPLANET | November 23, 2022

IMPLANET a medical technology company specializing in vertebral implants, announces the signing of an agreement with SMTP Technology Co., a high-tech medical device company specialized in the manufacturing and marketing of ultrasonic medical equipment, for the exclusive distribution of its latest generation ultrasonic surgical scalpel in France. Adam Li, GMA & International Business Manager at SMTP Technology Co., stated: “We are delighted with the signing of this contract tying us to IMPLANET, which will henceforth ensure the distribution of our latest generation ultrasonic surgical scalpel. This innovative solution will increase surgical efficiency while ensuring greater patient safety. Thanks to this collaboration with IMPLANET, a company recognized for its expertise in the field of spine surgery and its foothold in French medical centers, we are strengthening the credibility of our solutions for their international deployment”. “This latest contract, which comes close on the heels of the commercial and technological partnership signed with Sanyou Medical, further emphasizes the pertinence of our repositioning on the spine market. The surgical scalpel developed by SMTP, through its innovation and ease of use, should meet the needs of surgeons and patients alike. IMPLANET is proud to be able to work with one of the only players in the world capable of developing this type of product based on ultrasound”. Ludovic Lastennet, IMPLANET’s Chief Executive Officer The ultrasonic surgical scalpel developed by SMTP Technology Co. can support both open surgery, minimally invasive surgery and endoscopic intervertebral spine surgery. This product, which has been granted marketing clearance in China, the European Union and the United States, stands out through its innovative design, guaranteeing enhanced surgical safety. Thanks to the smaller amplitude of its cutting tip, the scalpel cuts bone tissue by the acceleration of hundreds of thousands of mechanical vibrations per second while sparing soft tissue. The agreement signed today between IMPLANET and SMTP Technology Co. follows the signing of the distribution contract and technological partnership with Sanyou Medical, of which SMTP Technology Co. is a subsidiary. This new agreement gives IMPLANET exclusive rights to distribute the scalpel on the French market. SMTP Technology Co., founded in 2010, is a high-tech medical device company focusing on the innovative research and development, manufacturing and marketing of ultrasonic surgical equipment. The ultrasonic osteotomy surgical system manufactured by SMTP Technology, which supports both open surgery and minimally invasive surgery under the channel and intervertebral endoscope, has been granted marketing approval in China, the European Union and the United States. Based in the Zhangjiagang free trade zone in Jiangsu province, SMTP is a subsidiary of the Sanyou group with 100 employees and revenue of 14 million euro. About IMPLANET Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its activity revolves around a comprehensive innovative solution for improving the treatment of spinal pathologies complemented by the product range offered by Orthopaedic & Spine Development (OSD), acquired in May 2022. Implanet’s tried-and-tested orthopedic platform is based on the traceability of its products. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration in the United States, the CE mark in Europe and ANVISA approval in Brazil. IMPLANET employs 39 staff and recorded a consolidated revenue of €6.1 million in 2021. Based near Bordeaux in France, IMPLANET opened a US subsidiary in Boston in 2013. IMPLANET is listed on the Euronext Growth market in Paris.

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HEALTH TECHNOLOGY

Annuo Med Tech Solutions Enters Partnership Agreement with WeKo GP

Annuo Medical Technology Solutions Pty Ltd | October 17, 2022

New health networking platform, Annuo™, has entered a working agreement with WeKo GP to assist with the identification and treatment of patients with chronic disease in Australia. This key partnership will facilitate the management of people living with chronic disease by General Practice teams using WeKo and Annuo™. WeKo’s Clinical System solution launched in 2019 and provides proactive chronic disease screening and detection based on patient medical data. “We believe our solutions are highly complementary and have the ability to offer an amazing patient and clinician experience,” commented WeKo Founder, Ross Hadfield. “We are excited to announce a trial partnership between Annuo and WeKo GP which will open up more possibilities for Annuo™ to help the 10.8M Australians currently living with chronic disease,” Dr Jeni Wellington, Founder and CEO of Annuo Med Tech Solutions At a high-level, the partnership will facilitate the identification and treatment of patients at high risk of chronic disease, using the Annuo platform and WeKo’s Clinical System. It will ensure patients are engaged in the creation of an agreed care plan and that the clinical teams involved are fully supported. About Annuo Med Tech Annuo Med Tech Solutions is a new Australian digital health technology company developing Annuo - a healthcare networking platform for doctors, patients and allied health professionals. Annuo™, is the first medical networking platform in Australia designed by specialists. More than that, Annuo™ is advocating for collaborative care for patients living with chronic disease in Australia. With 47% of Australians today living with one or more chronic diseases, there has never been a better time to help improve the lives of everyday people trying to navigate their treatment. Annuo™ encourages people living with chronic disease to engage with their treatment in an holistic way. Annuo promotes collaborative care for patients and is inclusive of those seeking to make diet, exercise and alternate therapies as part of their treatment planning. Annuo™ will engage with healthcare providers and enable them to better connect with their patients through the digital health space. The platform comes fully customised for each medical specialty at a competitive price.

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FUTURE OF HEALTHCARE, DIGITAL HEALTHCARE

BioNJ Hosts Its Inaugural Health Equity in Clinical Trials MBA Business Plan Case Competition

BioNJ | December 07, 2022

BioNJ, New Jersey's life sciences trade association, hosted an Inaugural Health Equity in Clinical Trials MBA Business Plan Case Competition on Saturday, December 3, at Rutgers Business School. BioNJ's Business Plan Case Competition, which is part of a broader BioNJ strategic initiative of Health Equity in Clinical Trials, was designed to promote the next generation of diverse clinical trial innovators and identify innovative approaches and successful models that can be used nationally to strengthen diversity in clinical trials and expand health equity. BioNJ believes that health equity in clinical trials is critical to deepening the understanding of the safety and efficacy of medicines in under-represented populations, expanding access to medical innovation for these populations and increasing dialogue and trust among the biopharma industry, communities and healthcare systems. By discovering new approaches, utilizing new technologies and developing new business standards to make trials more accessible, we can work to create more agile, efficient and Patient-centered medical research. Eight teams, competing for more than $20,000 in prize money, were tasked with developing a business plan defining a new solution, application or technology to help address this important and challenging problem. Teams identified one particular type of health disparity on which to frame their proposed solutions and connected with community-based organizations to better understand the real-world barriers that exist for their chosen populations to engage in clinical trials. The disease areas on which the respective teams focused included Alzheimer's, heart failure, multiple sclerosis, diabetes type 1 and type 2, colorectal and cervical cancers, and oncology. "There is an urgent need to bring more diversity to clinical trials in order to better serve Patients and their communities…thereby helping to address health inequities. Only by improving diversity in clinical trials will we be able to deepen our understanding of the safety and efficacy of medicines for all populations. I am extremely proud of our teams. Each of the business plans offered a unique out-of-the-box solution – helping advance our ambition to have no Patient left behind." Amadou Diarra, Ph.D., Senior Vice President, Global Policy, Advocacy & Government Affairs for Bristol Myers Squibb; BioNJ Board Member and Chair of the BioNJ Health Equity in Clinical Trials Initiative Live pitch presentations were made throughout the day to a Panel of Judges comprised of industry experts Naikia Atkinson, Director, U.S. Clinical Trials Diversity and Inclusion, Sanofi Schylr Greggs, Director, Technology Operations, Medidata Sharon Hanlon, Head, Clinical Trial Engagement & Enrollment, Bristol Myers Squibb Maribel Hernandez, Vice President, Clinical Operations & Special Projects, PTC Therapeutics Jack Rosenberg, Manager, Investments and Business Development, TrialSpark Del Smith, Co-Founder & CEO, Acclinate Lolita Smith, Program Manager, Rare Disease Diversity Coalition, Black Women's Health Imperative Matt Walz, CEO, TrialBee "Although ultimately three winning teams were presented with cash prizes, each team has made a difference for Patients by offering new solutions and technologies to better serve Patients, build community trust and address gaps in health care delivery," said Paul Howard, Ph.D., BioNJ Business Case Competition Steering Committee Chair and Senior Director, Public Policy for Amicus Therapeutics. "This is just the start as we work to share these proposals more broadly." A white paper with all of the presentations will be published in April and rolled out during BioNJ's acclaimed BioPartnering Conference – which brings together more than 500 industry professionals from around the globe. The three winning teams will present their plans during the April 18 BioPartnering Conference and all of the students are invited to attend to meet the community. About BioNJ BioNJ is the life sciences trade association for New Jersey, representing close to 400 research-based life sciences organizations and stakeholders across the healthcare ecosystem from the largest biopharmaceutical companies to early stage start-ups for nearly 30 years. Because Patients Can't Wait®, BioNJ is dedicated to ensuring a vibrant ecosystem where Science is Supported, Companies are Created, Drugs are Developed and Patients Have Access to Lifesaving Medicines.

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Spotlight

Based on a recent HIMSS Analytics survey, this paper reveals results that can help providers assess their progress and compare it to that of other providers, offering an idea of how to better identify and address chinks in the organization's armor.

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