Additive Orthopaedics® Announces additive manufacturing Capability with Patient Specific Implant Locking Technology

Additive Orthopaedics, LLC | October 23, 2020

Additive Orthopaedics® Announces additive manufacturing Capability with Patient Specific Implant Locking Technology
Additive Orthopaedics, LLC., the leader in 3D printed orthopaedic foot and ankle devices, announces a novel breakthrough in orthopaedic additive manufacturing with their ability to incorporate locking technology in all of their Patient Specific Implants. The patent pending technology can be incorporated in Additive Orthopaedics Patient Specific 3D Printed Plates and Patient Specific 3D Printed Bone Segments. According to Luciano Bertolotti, Director of Engineering for Additive Orthopaedics, "Locking technology is straightforward for off the shelf implants in which the machining process for the screw hole threads is set up once and can be manufactured in high volumes.

Spotlight

Salt form screening (if applicable) is an important early step in inhalation dosage form selection. Approximately 50% of active pharmaceutical ingredients (APIs) in approved products are salt forms,1 and that proportion is slightly higher (approx. 60%) for APIs in approved inhalation products. For each type of formulation (e.g. solution versus suspension) or dosage form, it is conceivable that a different salt form will be most amenable for development. As with all pharmaceutical development, understanding the physical and chemical properties of the active pharmaceutical ingredient (API), and its different forms if applicable, is critical in defining the dosage form design space.

Spotlight

Salt form screening (if applicable) is an important early step in inhalation dosage form selection. Approximately 50% of active pharmaceutical ingredients (APIs) in approved products are salt forms,1 and that proportion is slightly higher (approx. 60%) for APIs in approved inhalation products. For each type of formulation (e.g. solution versus suspension) or dosage form, it is conceivable that a different salt form will be most amenable for development. As with all pharmaceutical development, understanding the physical and chemical properties of the active pharmaceutical ingredient (API), and its different forms if applicable, is critical in defining the dosage form design space.

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PHARMA TECH

FDA Grants Breakthrough Device Designation to JelikaLite

JelikaLite Corp | January 07, 2022

JelikaLite Corp, a medical technology company, announced that the U.S. Food and Drug Administration has granted the Breakthrough Device Designation to its Cognilum System for the reduction of symptoms of moderate to severe autism spectrum disorder in pediatric patients who are 2 to 6 years of age. The FDA’s Breakthrough Device Program recognizes medical devices that meet the criteria and hold the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or condition. Data from a pilot study suggests that Cognilum, a wearable medical device, can significantly improve the symptoms of children living with autism. If approved, it will offer families access to a home-based, easy-to-use, and cost-effective treatment for children with autism not available anywhere else. Autism is a serious developmental disorder that impacts families around the globe. JelikaLite Corp. believes that it can provide relief to patients and families by reducing children's autism symptoms. Children will be able to better integrate into the society and have more fulfilling lives. Their caregivers can lead less stressful lives and both insurance companies and the government will be able to spend less money on effective intervention, special education and lifelong residential care. The Breakthrough Device Designation for Cognilum was based on the results of a double-blind, placebo controlled clinical trial of 30 pediatric patients with moderate to severe autism. The trial showed both safety and efficacy of this technology. By combining non-invasive brain stimulation with near-infrared light, EEG sensors, and AI personalization platform, Cognilum demonstrated improvements in autism symptoms through gains in communication and daily living skills. "We are thrilled that the FDA recognizes that we are developing a novel technology with a potential to change the landscape in the current approach to Autism. For some of the participants in our active condition, the positive change was so dramatic that their parents expressed their desire to continue the treatment even after the study was over. We recognize that Autism is a spectrum, and no two children are alike; our ultimate goal is to develop a personalized approach to every child based on their unique needs and challenges.” Dr. Eugenia Steingold, Chief Science Officer of JelikaLite JelikaLite’s vision is to bring Cognilum into the homes of families raising children with autism around the globe. This device is truly unique as it seeks to offer a personalized treatment for each child with an integrated feedback loop for both caregivers and doctors. About JelikaLite Based in New York, JelikaLite was launched in 2019 to develop Cognilum™, an innovative solution to permanently reduce children's autism symptoms, enabling better integration into society and reducing lifelong costs. Cognilum™ is a data-device integrated system, where a wearable non-invasive therapeutic medical device that provides neurostimulation treatment is combined with an AI personalization platform. JelikaLite has been founded and run by a multidisciplinary team, with experts in autism clinical therapy, transcranial photobiomodulation, commercialization of medical devices, artificial intelligence, product management, and finance.

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BUSINESS INSIGHTS

Virpax Pharmaceuticals Engages Torreya Capital to Advise on Global Partnering Efforts

Torreya Capital, Virpax Pharmaceuticals | April 23, 2021

Virpax® Pharmaceuticals, Inc. reported today that it has appointed Torreya Capital, LLC as the Company's sole financial adviser for its partnering and licensing activities in strategic global markets. Torreya is a leading investment bank that has supported more than $100 billion in life sciences transactions since its establishment in 2007. “We are thrilled to be collaborating with Torreya to extend our partnerships in key markets,” said Anthony Mack, Chairman, and CEO of Virpax Pharmaceuticals. "There is an increasing worldwide need for non-opioid, non-addictive pain treatments, and we agree that our product candidates, EpoladermTM, ProbudurTM, and EnveltaTM, will provide a competitive advantage in their target markets," Mr. Mack concluded. "We look forward to assisting Virpax Pharmaceuticals in identifying strong regional partners for their innovative acute and chronic pain product candidate pipeline,” said Torreya Partner Tom Bird. "Virpax's product candidates include proprietary technologies that can enable the product candidates to provide enhanced benefits while providing non-addictive pain relief.” About Torreya Torreya is a global investment banking boutique that works with life sciences industries. Since its inception in 2007, the company has closed over $100 billion in transactions spanning branded pharmaceutical, biotechnology, generic pharmaceutical, and life sciences firms in nearly 250 assignments. Their associates are senior bankers and executives with extensive industry expertise, insights, and networks. They are a preferred advisor for businesses seeking secure, conflict-free, and knowledgeable advice on M&A, capital markets, licensing, and asset sale transactions. The breadth of Torreya's global footprint separates it from any other life sciences advisory practices. About Virpax Pharmaceuticals Virpax is developing branded, non-addictive pain management product candidates by optimizing and enhancing drug delivery using its proprietary technologies. Virpax is seeking FDA approval for its three proprietary drug delivery systems. EpoladermTM is a metered-dose topical diclofenac spray film formulation being used to treat acute musculoskeletal pain and osteoarthritis. ProbudurTM is a liposomal bupivacaine formulation for a single injection that is being used to treat post-operative pain. EnveltaTM is an intranasal molecular-envelope enkephalin formulation that is being developed to treat acute and chronic pain, particularly cancer-related pain. Virpax is also developing its PES200 product candidate to treat post-traumatic stress disorder (PTSD) and its MMS019 product candidate to prevent viral replication caused by influenza or SARS-CoV-2 using its intranasal Molecular Envelope Technology (MET).

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PHARMA TECH

CareRx Applauds Ontario Ministry of Health's Pause of Planned Fee Changes

CareRx | January 18, 2021

CareRx Corporation ("CareRx" or the "Company") (TSX: CRRX), Canada's leading provider of specialty pharmacy services to seniors, is pleased that the Ontario Ministry of Health has announced that it will pause for one year previously scheduled changes to long-term care pharmacy funding, which were scheduled to go into effect on April 1, 2021. Under certain amendments to the Ontario Drug Benefit Act that came into effect on January 1, 2020, the reimbursement model for long-term care pharmacies in Ontario was changed from a fee-for-service model to a fee-per-bed capitation model under which pharmacies receive a fixed professional fee for all pharmacy services provided to residents in long-term care homes. The fee for 2020, which was prescribed at $1,500, was scheduled to decline to $1,400 per bed serviced on April 1, 2021. The step-down in capitation has now been paused until April 1, 2022. "Long-term care homes and their staff have faced unprecedented challenges during COVID-19," said David Murphy, President and Chief Executive Officer of CareRx. "This pause will ensure that pharmacies like CareRx can continue to deliver the same exceptional partnership and service offering to long-term care homes and help alleviate the burden COVID-19 has placed on home staff. We want to thank Minister Elliott, Minister Fullerton and the Ontario Government for their ongoing dialogue and commitment to protecting the wellbeing of residents in long-term care." About CareRx Corporation CareRx is Canada's leading provider of specialty pharmacy services to seniors. We serve approximately 50,000 residents in over 900 seniors and other communities (long-term care homes, retirement homes, assisted living facilities, and group homes). We are a national organization with a large network of pharmacy fulfillment centres strategically located across the country. This allows us to deliver medications in a timely and cost-effective manner and quickly respond to routine changes in medication management. We use best-in-class technology that automates the preparation and verification of multi-dose compliance packaging of medication, providing the highest levels of safety and adherence for individuals with complex medication regimes. We take an active role in working with our home operator partners to promote resident health, staff education, and medication system quality and efficiency.

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