IceCure Medical Ltd | August 30, 2022
IceCure Medical Ltd. developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing as an alternative to surgical tumor removal, announced it has submitted a regulatory filing with the Department of Medical Equipment and Construction of Vietnam's Ministry of Health for the ProSense System and accessories.
The application covers indications including benign and malignant breast tumors, benign and malignant lung tumors, benign and malignant liver tumors, kidney cancer, ablation of cancerous or malignant tissue, musculoskeletal tumors, and other indications.
Vietnam's medical device market was valued at $1.4 billion in 2019 and was projected to grow 10% annually through 2024, according to the U.S. Department of Commerce, with overall healthcare expenditures in the country totaling $17 billion. Liver, lung, and breast cancer were the three most prevalent cancers in Vietnam in 2020 according to the World Health Organization.
"Asia is a significant market for ProSense and Vietnam is one of the fastest growing healthcare markets in the region. Having started the regulatory process in Vietnam, we anticipate high interest from potential distributors in the country. This comes on the heels of our recent successes in the region with Shanghai Medtronic Zhikang Medical Devices Co. Ltd. in China and Terumo in Japan, Singapore, and Thailand."
IceCure CEO, Eyal Shamir
About IceCure Medical Ltd.
IceCure Medical Ltd. develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared to-date by the U.S. Food and Drug Administration and approved in Europe with the CE Mark.
Standigm | August 19, 2022
Standigm Inc. the leading workflow artificial intelligence (AI) drug discovery company, announced the appointment of Chief Business Officer Carl Foster. Based in our U.S. office, Foster will be responsible for expanding strategic partnerships for novel drug target discoveries and first-in-class lead candidate identifications.
"Carl has established a reputation for increasing company value. He has significant experience building and growing biotech companies, like Standigm, through creative deal-making. We're confident Carl can help us meet our aggressive goals."
Jinhan Kim, CEO of Standigm
Foster spent over 30 years working for drug and platform technology companies in various areas including genomics, proteomics and antibodies. Throughout his career, he has built a strong track record of business planning, establishing strategic relationships and financial modeling.
Foster began his career with Merck and Co., Inc. where he had spent nine years in business development, marketing, and sales. Most recently, he was executive vice president, business development for Cempra Pharmaceuticals. Prior to that, he was CEO of Jurilab, a European-based genomics company. Foster has also held vice president-level positions at Nanogen, King Pharmaceuticals, Oxford GlycoSciences and Praecis Pharmaceuticals. In addition, he was general manager of Intracel BV, a Netherlands-based immunology company and managing director of Ferghana Partners, a New York-based investment banking group. Foster holds an MBA in marketing and an M.S. in biochemistry from the University of Kansas.
"Our goal is to shorten the drug discovery process, reduce costs and increase the probability of success by combining the Standigm AI platform with disease-specific data from our strategic partners," said Foster. "I believe combining AI with drug discovery will result in major advances in how we understand diseases and create solutions. Standigm's first-class AI platform is backed by a strong team of biologists, chemists and AI engineers who have collectively created a tremendous opportunity for me. I look forward to helping them build a novel and industry-leading company."
Standigm is a workflow AI-driven drug discovery company headquartered in Seoul, South Korea and subsidiarized in Cambridge, U.K. and Cambridge, MA. Standigm has proprietary AI platforms encompassing novel target identification to compound design, to generate commercially valuable drug pipelines. Founded in 2015, Standigm has established an early-stage drug discovery workflow AI to generate multiple First-in-Class compounds within average seven months. Pursuing full-stack, AI-driven industrializing drug discovery, Standigm has achieved the automation of molecular design workflow, and the automation effort has been expanding to the whole drug discovery process based on Standigm AI platforms, including Standigm ASK™ for novel target discovery, Standigm BEST™ for novel compound generation and Standigm Insight ™ for novel indication.
Corium, Inc. | September 20, 2022
Corium, Inc., a fully-integrated biopharmaceutical company leading the development and commercialization of novel central nervous system therapies, announced publication of its phase 1 healthy volunteer study results for ADLARITY in the peer-reviewed Journal of Alzheimer's Disease. The article, "Comparison of Steady-State Pharmacokinetics of Donepezil Transdermal Delivery System with Oral Donepezil," reports that Corium's novel once-weekly Alzheimer's dementia treatment delivered drug exposure equivalent to oral donepezil while presenting lower gastrointestinal (GI) adverse events overall compared to oral donepezil. The article is currently available online and expected to be published in the hardcopy of the Journal of Alzheimer's Disease, Volume 90, Issue 1, on October 25, 2022.
"Transdermal delivery offers meaningful potential benefits over oral administration, including ease of use, maintenance of steady concentrations of drugs, reduced gastrointestinal adverse effects, and better treatment compliance. The availability of a transdermal formulation of donepezil gives clinicians, patients, and their caregivers an important new option to consider when treating dementia of the Alzheimer's type," said study co-author Pierre N. Tariot, M.D., director of the Banner Alzheimer's Institute in Phoenix, AZ.
"The study demonstrated the equivalent exposure of Adlarity to oral donepezil and supports the use of ADLARITY as a compliant and safe once-weekly dosing regimen for treatment of patients with dementia of the Alzheimer type. The trial also shows Corium's commitment to addressing the unmet needs of patients with CNS disorders."
Charles Oh, M.D., Chief Medical Officer of Corium
ADLARITY Transdermal System: Equivalent to Oral Donepezil Exposure, Fewer GI Adverse Events Overall
In the trial, investigators compared the extent of donepezil exposure from the once-weekly ADLARITY to a once-daily oral donepezil formulation in 60 healthy adults (NCT04617782). The trial included three treatment periods of 5 weeks each. In the first period, all the participants received ADLARITY weekly, which provided 5 mg/day of donepezil. In the second period, participants were randomized to receive either 10 mg/day once-weekly ADLARITY or 10 mg/day daily oral donepezil, followed by switching to the alternative treatment, ADLARITY or oral donepezil, in the third period. All the participants knew which treatment they received in this open-label trial. Investigators examined the amount of donepezil in the participants' blood, including the maximum plasma concentration (Cmax) and the total amount of drug exposure (area under the curve or AUC).
About Alzheimer's Disease
Alzheimer's disease is a progressive and irreversible brain disorder. It involves changes in brain tissue including abnormal buildup of proteins as well as loss of neuron function. The resulting damage leads to the loss of remembering, reasoning, and thinking abilities. The related behavioral changes include the loss of independence in activities of daily living and self-care. Dementia ranges in severity from mild, when it is just beginning to affect a person's functioning, to moderate, to severe, when the person must depend on others for the basic activities of day-to-day life. Patients with advanced Alzheimer's disease may be unable to chew and swallow easily.
Corium, Inc., is a fully-integrated biopharmaceutical company that is leading the development and commercialization of CNS therapies that provide physicians with innovative treatment options for patients, their families, and their caregivers. Corium is commercializing two U.S. FDA approved products, ADLARITY and AZSTARYS.
About Gurnet Point Capital
Gurnet Point Capital is a unique healthcare investment platform within the B-Flexion group and led by a team with deep expertise in an industry for which they share a passion, both as investors and senior executives. GPC invests long-term capital and supports entrepreneurs in building a new generation of companies that deliver outsized returns through active ownership. Based in Cambridge, MA, its remit encompasses life sciences and health care focused businesses, with a particular emphasis on businesses that have high growth potential in the product development and commercialization stages of their evolution. With its strategy of driving best in class operational transformation for these businesses, to create social impact while generating significant economic value, GPC is able to deliver differentiated results for its investors and partners.
Mauna Kea Technologies | July 12, 2022
Mauna Kea Technologies inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy platform, and Tasly Pharmaceuticals announced the execution of an agreement to form a Joint Venture.
Under terms of the agreement, Tasly and Mauna Kea will form a Joint Venture that will (i) commercialize selected Cellvizio indications in China, (ii) develop and commercialize Cellvizio globally in the fields of Neurology and Neurosurgery, and (iii) manufacture Cellvizio units for the Chinese market. The JV will utilize both existing distribution partners and its own network of China-based marketing professionals to accelerate market adoption.
In exchange for contributing licenses and other intellectual property to the JV, Mauna Kea will receive cash payments totaling $10 million, a 44.1% equity interest in the JV, and a 5-year commitment to purchase minimum quantities of Cellvizio systems and probes. Mauna Kea’s equity holdings are net of shares issued to Cenponts Tech Limited in consideration for strategic advisory services provided in connection to the transaction. The Joint Venture will be majority owned and funded by Tasly and jointly managed by Tasly and Mauna Kea.
The Joint Venture will be in an immediate position to leverage Mauna Kea’s position as global leader in probe and needle-based confocal laser endomicroscopy, with its FDA clearance for neurosurgery applications, its broad regulatory clearances in the Chinese market as well as its significant installed based in leading hospitals in China.
“We are delighted to partner with Tasly Pharmaceuticals, a life sciences leader in Asia-Pacific with a global presence. This transaction both expands the addressable market for Cellvizio and increases Mauna Kea’s capacity to invest further in product and clinical development, including molecular imaging and artificial intelligence. This announcement builds on the strategic repositioning we announced in December 2021 and our emphasis on forming capital-efficient partnerships that leverage the commercial reach of global biopharma and medtech firms while increasing patient access to Cellvizio.”
Sacha Loiseau, Ph.D., founder and Chairman of Mauna Kea Technologies
Kaijing Yan, Chairman of Tasly Pharmaceuticals Group, commented: “The field of biomedical engineering is an important part of Tasly Pharmaceuticals’ second growth curve strategy. The cooperation with Mauna Kea Technologies will enable us to quickly access large markets in China addressed by the multiple clinical applications of Confocal Laser Endomicroscopy. The recent advances in molecular imaging with Cellvizio are also of great interest to us since Tasly Pharmaceuticals could assist the Joint Venture in developing new combinations of Cellvizio with novel molecular markers, aligned with our vision of providing integrated solutions from diagnosis to treatment. We very much look forward to a fruitful and rich collaboration with Mauna Kea Technologies.”
About Tasly Pharmaceuticals Group
Adhering to the business mission of "To share the joy of health with all", Tasly has always been promoting the integrative development of traditional Chinese medicine and modern medicine. Tasly continuously focuses on the three disease fields of cardio-cerebro-vascular diseases, digestive and metabolic diseases and tumors, which have the largest market share and the fastest development in China. It is committed to providing drug R&D that is urgently needed for clinical use and even addresses the unmet needs in China's clinical market. By leveraging the coordinated development advantages of modern TCM, biological medicine and chemical medicine, it carries out the strategic layout of innovative drugs and continues to maintain its leading position in the industry and the development momentum of R&D and innovation.
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions.