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DIGITAL HEALTHCARE, MEDICAL DEVICES

Sofwave Medical Announces FDA Clearance of SUPERB™ Technology For Cellulite

SofWave Medical, Ltd. | December 20, 2022 | Read time : 03:00 min

Sofwave Medical

Sofwave Medical Ltd an emerging leader in energy-based non-invasive, aesthetic medical devices announced the U.S. Food and Drug Administration’s clearance of Sofwave’s SUPERB™ technology to be used for the short-term improvement in the appearance of cellulite.

Dr. Shimon Eckhouse, Chairman & Co-Founder commented on the occasion, “We are pleased to receive FDA clearance to use the Company's proprietary SUPERB™ technology to improve the appearance of cellulite in the short term. Non-invasive treatment of cellulite is one of the most desired body treatments in medical aesthetics because of the high prevalence of cellulite in women of all ages and the lack of effective and safe solutions with no patient down-time. Sofwave has shown once again that its investment in the development of the SUPERB™ technology to treat highly prevalent aesthetic indications bears significant fruit and will support the continued rapid growth of the Company. Our disruptive SUPERB™ technology was designed to be efficient and easy to use, and the Company invests and plans to continue investing in bringing innovative solutions to the growing aesthetic technology market generating great ROI to our physician customers.”

In the clinical trials submitted to the FDA as part of the 510(k) application in support of the cellulite FDA clearance, the Company conducted a multi-site clinical study that evaluated the safety and effectiveness of the device for the non-invasive dermatological aesthetic improvement in cellulite appearance. A total of 68 women were treated at 4 sites in the United States. Eligible patients received 2 treatments using SUPERB™ technology on one side (right or left) of the lateral / posterior upper thigh or buttocks. Serial clinical photographs were collected under standardized conditions before treatment and at the 3-month follow-up visits. Photographs were assessed by blinded independent reviewers to identify pre-treatment images when compared to post treatment images and to grade the pre-treatment and post-treatment images using the Cellulite Severity Scale (CSS). Improvement was also evaluated using the Global Aesthetic Improvement Scale (GAIS) and Laxity Scale (LS). Safety assessments included evaluation of adverse events via physician examination during and after the treatment.

Post-study, the blinded reviewers correctly identified the post treatment images for 89% of the subjects. No serious or unanticipated adverse event was reported during the study.

“The FDA's clearance of SUPERB™ for use in cellulite could not have come at a timelier moment. Our dedicated U.S. direct sales force is positioned to expand our growing presence and market share of the aesthetic medical device market in the U.S. In addition, our recent regulatory clearance in Brazil further extends our global footprint, letting us immediately launch sales in this important and sizeable market. Furthermore, our partnership in China with HTDK, one of Asia's strongest healthcare solutions providers, covers our expansion in that territory. Our focused commitment across these major markets, will go a long way towards further accelerating global sales and brand-recognition of our devices in the upcoming new year.”

Lou Scafuri, Sofwave's CEO

In 2021, the FDA cleared additional indications for SUPERB™ technology, for lifting the eyebrow and lifting lax submental tissue (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental neck regions. In addition, the Sofwave SUPERB™ technology is also cleared by the U.S. FDA for a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles.

About SUPERB™
Sofwave’s state-of-the-art SUPERB™ Technology addresses the growing demand for non-invasive treatments that deliver noticeable results in non-invasive treatment of highly desired aesthetic indications. The device’s cooled transducers are directly coupled to the epidermis, creating a unique 3D array of volumetric thermal zones that deliver parallel energy simultaneously, heating precisely at the right depth in the mid-dermis. A single Sofwave treatment reduces facial wrinkles in a fast 30 to 45 minute non-invasive treatment with no interruption to a patient’s daily routine or post-treatment discomfort.

About Sofwave Medical
Sofwave Medical Ltd. has implemented an innovative approach to wrinkle reduction lifting and cellulite using proprietary breakthrough technology. SUPERB™, Synchronous Ultrasound Parallel Beam technology is FDA-cleared to improve facial lines and wrinkles, lifting the eyebrow and lifting lax submental tissue (beneath the chin) and neck tissue and the short term improvement in the appearance of cellulite providing physicians with smart yet simple, effective, and safe aesthetic solutions for their patients. 

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DIGITAL HEALTHCARE, MEDICAL DEVICES

Sharps Technology Begins Manufacturing at its Hungary Facility for the Company's Innovative Syringe Products

Sharps Technology Inc | December 21, 2022

Sharps Technology, Inc. an innovative medical device and drug delivery Company offering patented, best-in-class syringe products, announces they have commenced manufacturing of their much-needed ultra-low waste smart safety syringe products in their European operation in Hungary. The plant has been producing products and will begin shipments to support the distribution and sales agreement with Nephron Pharmaceuticals by the end of the year, and customer agreements in Europe in early 2023. The production of these specialty syringe products will ramp up over the next several months to increase supply. Sharps innovative syringe designs provide a beneficial set of features and advantages for the healthcare industry. These syringe product features include a combination of ultra-low waste, passive and active safety, and reuse prevention. By combining all these features and building them into a portfolio of syringe offerings, it will create product platforms that can help drive down the cost of healthcare treatments. “This is a transformative point for our company as we move from a pre-revenue research & development start-up to a true manufacturing company that should generate revenue in the first half of 2023. Today’s healthcare providers are responsible for managing their supply chains and driving down their total cost of ownership (TCO) for medical treatments. Sharps Technology will be able to offer products that can directly support those programs. At Sharps Technology, we feel that by using better drug delivery technology, we can help create additional medical treatments at no additional cost for patients that need them." Robert Hayes, Sharps Technology CEO "We look forward to a bright future at Sharps Technology," concluded Mr. Hayes. "The recently signed distribution agreement with Nephron Pharmaceuticals accelerates the sales plan for our innovative syringe products that are currently being produced in the Sharps plant in Hungary. The ability to pull forward our sales plan for customers in the US will create a unique opportunity for early revenue at Sharps. We expect to have our first products available for sale in the US by the end of January 2023, with additional products to be added to the distribution network by mid-year of 2023." When healthcare providers use ultra-low waste syringes with multi-dose vials, it allows for the availability of up to 20% to 40% more medication for patients that need the treatment. This medication availability is created by using more efficient syringes designated as low-waste and ultra-low waste products, and not trapping medication within the syringe after the dose is given. The use of standard syringes that are not designated as low waste or ultra-low waste products typically creates a dead space area within the syringe where excess medication is trapped and cannot be used. This dead space then causes the healthcare provider to throw away the unused medication. The trapped medication in the dead space of a standard syringe can waste as much as 100 microliters of medication or more. The Pharmaceutical companies that fill their medication into vials understand this and must then overfill the vial with drug therapy to compensate for the problem. As the costs for medication and medical treatments rise, the discarded medication can cost the industry millions of dollars, or more, globally. The purchase of the European facility was finalized in the summer of 2022 and Sharps has invested in infrastructure and equipment upgrades to prepare the plant for a full manufacturing schedule. Syringe products produced by Sharps comply with all applicable FDA and ISO requirements and have been awarded the European Union’s CE Mark. The Sharps Hungary team, led by General Manager Filippo Filippi, brings together a dedicated and knowledgeable manufacturing force, with more than 20 years of experience in supplying the world with high quality, innovative syringe products. Prior to the GM position, Filippi’s career spanned years of building, managing, and supporting multiple manufacturing sites across Europe, Asia, and Africa. The Hungary plant is vertically integrated in that it has the capability to manufacture the syringe components by injection molding, assemble the devices on automated lines or by manual assembly if required, and to sterilize the products on-site through the Ethylene Oxide sterilization process. This last stage of the syringe manufacturing process is unique in the industry and gives Sharps an advantage in supporting shortened lead times as compared to the common need to utilize a third-party for sterilization. The plant has manufacturing capacity to supply more than 50 million units today and the facility could be expanded to produce 250 million units or more over the next couple of years. About Sharps Technology Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and ready to use processing. The company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US..

Read More

FUTURE OF HEALTHCARE, MEDICAL DEVICES

Catalyst Solutions Announces Third-Party Administration White Paper Publication

Catalyst Solutions | December 22, 2022

Catalyst Solutions announces the publication of the white paper, Third Party Administration for Healthcare Payers. This white paper reviews the unique needs that self-funded and fully-insured plans might have for Third Party Administration as well as, the services and benefits TPAs provide. As an industry, healthcare continues to experience constant change. The landscape is dynamic, and new challenges are on the horizon. Mergers, acquisitions, and partnerships are occurring at an unprecedented rate - and the government continues to introduce mandates to which the healthcare plan must adhere. These factors continue to add demands on plans that are already facing budgetary and resource constraints. "To manage these challenges healthcare payers are increasingly outsourcing business processes to Third Party Administrators. Just like in organizations, outsourcing allows them to focus on what they do best, which is: improving the healthcare outcomes of their membership." Scott Martin, President of Catalyst Solutions TPAs deliver administrative support to self-funded businesses and fully-insured healthcare plans. Both are increasingly outsourcing day-to-day operational services to a TPA, which is driving significant cost savings and reducing the administrative burden. Catalyst Solutions provides a full suite of TPA services. Its team of fully-trained, US-based employees can deliver the operational and technology functions required by a healthcare plan or self-funded business. Catalyst seeks to maximize the performance of healthcare plans by taking a holistic view of people, process, and technology. "Catalyst engages plans at a strategic level," Scott Martin said, "aligning our outsourcing services to our customer's business goals. We use our industry expertise to anticipate our customers' long-term needs. Our services don't end with outsourcing – we become trusted advisors in helping our customers achieve a better future." About Catalyst Solutions Catalyst Solutions has an extensive history of exclusively serving the payer industry. With 20+ years of deep industry expertise, Catalyst provides outsourced BPO, IT, and consulting services. As a diversity-certified, woman-owned company based in the U.S., our mission is to help insurance payers drive down costs, optimize revenue, and most importantly, improve member healthcare outcomes. We deliver comprehensive and flexible solutions that meet the unique needs of payers, and we are committed to exceeding customer expectations by providing unmatched, white-glove service. We are passionate about making positive and measurable change on behalf of the clients we serve and the communities in which we live.

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HEALTH TECHNOLOGY, MEDICAL DEVICES

19Labs and MOH Launch Historic Telemedicine Project to Transform Healthcare in Guyana

19Labs | December 20, 2022

In cooperation with the Ministry of Health and the Georgetown Public Hospital Corporation a telemedicine pilot program with GALE eClinics was launched in four remote areas of Guyana. "We have reached a milestone and begin a journey that has the potential to transform health." Dr. Leslie Ramsammy, GPHC Board Chairman During the Telemedicine Launch, 19Labs CEO, Ram Fish, joined Guyana's Health Minister, Dr. Frank Anthony, in Masakenari, or as it is better known locally, Gunns Village. They were welcomed by the village Toshao, Paul Chekema, and the village residents. Using the newly installed eClinic system, Gunns was able to connect to the Georgetown Public Hospital and the three other villages that form part of this pilot program. The program's purpose is to provide equitable healthcare to all of Guyana's citizens. This keeps in line with the vision of Guyana's President, Dr. Ali, of creating a 'world-class' healthcare system for Guyana. Dr. Ramsammy, began the launch by saying: "Our ambition is to improve health care for all of our people, and as we understand that we can't put…a Georgetown public-level hospital in every village, we believe that citizens, in every part of the country, could get access to basic healthcare…We have reached a stage this morning, where we could launch Guyana's national telemedicine program." One of the major challenges in achieving such a vision is the remote locations with the lack of connectivity. Gunns Village is a 5-day boat and land trek during the rainy season when planes cannot use the local airstrip. 19Labs is proud to provide a solution as the four health posts that are part of this pilot are now connected to the world through the internet over satellite. With the GALE eClinic Telemedicine units, even the most isolated village now has access to top-quality medical care. In a very short time, Gunns went from an area that had no connectivity, electricity, and little medical equipment, to the ability to instantly connect to the healthcare and staff of the Georgetown Public Hospital. Dr. Anthony said: "With the technology we have now installed, this particular health center has a full complement of internet-enabled devices which we will…be able to do ultrasounds, ECGs, and a whole host of other things to help to assess the patient." GALE eClinics replicate the full clinical experience providing and filling the need for both general health and specialty care including prenatal, OBGYN, maternal, cardiac, and chronic condition management. Our partnership goes beyond a one-time fix. The local communities now have access to more opportunities. Ram Fish said: "This goes even beyond just health care, [this transforms communities]. The equity that it brings to us also opens the eyes of people and places to different cultures, and different ways of doing things…It's about empowering with technology local young women and men who really become the centers of the communities beyond just health…This is the beginning of a journey…We will expand and work together to really make healthcare equitable across Guyana and beyond." About 19Labs 19Labs is the creator of GALE, Next Generation Point-of-Care platform for pharmacies, schools, and rural communities. GALE brings together cutting-edge diagnostic technologies from industry leaders like Zoom, Elo, Amwell, Eko, Samsung Mobile, MIR, Omron, Viasat, and many others in one smart, efficient, and cost-effective platform. It was designed from the ground up to be operated by non-healthcare professionals, in locations with limited infrastructure and optimized for low bandwidth and intermittent connectivity.

Read More

DIGITAL HEALTHCARE, MEDICAL DEVICES

Sharps Technology Begins Manufacturing at its Hungary Facility for the Company's Innovative Syringe Products

Sharps Technology Inc | December 21, 2022

Sharps Technology, Inc. an innovative medical device and drug delivery Company offering patented, best-in-class syringe products, announces they have commenced manufacturing of their much-needed ultra-low waste smart safety syringe products in their European operation in Hungary. The plant has been producing products and will begin shipments to support the distribution and sales agreement with Nephron Pharmaceuticals by the end of the year, and customer agreements in Europe in early 2023. The production of these specialty syringe products will ramp up over the next several months to increase supply. Sharps innovative syringe designs provide a beneficial set of features and advantages for the healthcare industry. These syringe product features include a combination of ultra-low waste, passive and active safety, and reuse prevention. By combining all these features and building them into a portfolio of syringe offerings, it will create product platforms that can help drive down the cost of healthcare treatments. “This is a transformative point for our company as we move from a pre-revenue research & development start-up to a true manufacturing company that should generate revenue in the first half of 2023. Today’s healthcare providers are responsible for managing their supply chains and driving down their total cost of ownership (TCO) for medical treatments. Sharps Technology will be able to offer products that can directly support those programs. At Sharps Technology, we feel that by using better drug delivery technology, we can help create additional medical treatments at no additional cost for patients that need them." Robert Hayes, Sharps Technology CEO "We look forward to a bright future at Sharps Technology," concluded Mr. Hayes. "The recently signed distribution agreement with Nephron Pharmaceuticals accelerates the sales plan for our innovative syringe products that are currently being produced in the Sharps plant in Hungary. The ability to pull forward our sales plan for customers in the US will create a unique opportunity for early revenue at Sharps. We expect to have our first products available for sale in the US by the end of January 2023, with additional products to be added to the distribution network by mid-year of 2023." When healthcare providers use ultra-low waste syringes with multi-dose vials, it allows for the availability of up to 20% to 40% more medication for patients that need the treatment. This medication availability is created by using more efficient syringes designated as low-waste and ultra-low waste products, and not trapping medication within the syringe after the dose is given. The use of standard syringes that are not designated as low waste or ultra-low waste products typically creates a dead space area within the syringe where excess medication is trapped and cannot be used. This dead space then causes the healthcare provider to throw away the unused medication. The trapped medication in the dead space of a standard syringe can waste as much as 100 microliters of medication or more. The Pharmaceutical companies that fill their medication into vials understand this and must then overfill the vial with drug therapy to compensate for the problem. As the costs for medication and medical treatments rise, the discarded medication can cost the industry millions of dollars, or more, globally. The purchase of the European facility was finalized in the summer of 2022 and Sharps has invested in infrastructure and equipment upgrades to prepare the plant for a full manufacturing schedule. Syringe products produced by Sharps comply with all applicable FDA and ISO requirements and have been awarded the European Union’s CE Mark. The Sharps Hungary team, led by General Manager Filippo Filippi, brings together a dedicated and knowledgeable manufacturing force, with more than 20 years of experience in supplying the world with high quality, innovative syringe products. Prior to the GM position, Filippi’s career spanned years of building, managing, and supporting multiple manufacturing sites across Europe, Asia, and Africa. The Hungary plant is vertically integrated in that it has the capability to manufacture the syringe components by injection molding, assemble the devices on automated lines or by manual assembly if required, and to sterilize the products on-site through the Ethylene Oxide sterilization process. This last stage of the syringe manufacturing process is unique in the industry and gives Sharps an advantage in supporting shortened lead times as compared to the common need to utilize a third-party for sterilization. The plant has manufacturing capacity to supply more than 50 million units today and the facility could be expanded to produce 250 million units or more over the next couple of years. About Sharps Technology Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and ready to use processing. The company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US..

Read More

FUTURE OF HEALTHCARE, MEDICAL DEVICES

Catalyst Solutions Announces Third-Party Administration White Paper Publication

Catalyst Solutions | December 22, 2022

Catalyst Solutions announces the publication of the white paper, Third Party Administration for Healthcare Payers. This white paper reviews the unique needs that self-funded and fully-insured plans might have for Third Party Administration as well as, the services and benefits TPAs provide. As an industry, healthcare continues to experience constant change. The landscape is dynamic, and new challenges are on the horizon. Mergers, acquisitions, and partnerships are occurring at an unprecedented rate - and the government continues to introduce mandates to which the healthcare plan must adhere. These factors continue to add demands on plans that are already facing budgetary and resource constraints. "To manage these challenges healthcare payers are increasingly outsourcing business processes to Third Party Administrators. Just like in organizations, outsourcing allows them to focus on what they do best, which is: improving the healthcare outcomes of their membership." Scott Martin, President of Catalyst Solutions TPAs deliver administrative support to self-funded businesses and fully-insured healthcare plans. Both are increasingly outsourcing day-to-day operational services to a TPA, which is driving significant cost savings and reducing the administrative burden. Catalyst Solutions provides a full suite of TPA services. Its team of fully-trained, US-based employees can deliver the operational and technology functions required by a healthcare plan or self-funded business. Catalyst seeks to maximize the performance of healthcare plans by taking a holistic view of people, process, and technology. "Catalyst engages plans at a strategic level," Scott Martin said, "aligning our outsourcing services to our customer's business goals. We use our industry expertise to anticipate our customers' long-term needs. Our services don't end with outsourcing – we become trusted advisors in helping our customers achieve a better future." About Catalyst Solutions Catalyst Solutions has an extensive history of exclusively serving the payer industry. With 20+ years of deep industry expertise, Catalyst provides outsourced BPO, IT, and consulting services. As a diversity-certified, woman-owned company based in the U.S., our mission is to help insurance payers drive down costs, optimize revenue, and most importantly, improve member healthcare outcomes. We deliver comprehensive and flexible solutions that meet the unique needs of payers, and we are committed to exceeding customer expectations by providing unmatched, white-glove service. We are passionate about making positive and measurable change on behalf of the clients we serve and the communities in which we live.

Read More

HEALTH TECHNOLOGY, MEDICAL DEVICES

19Labs and MOH Launch Historic Telemedicine Project to Transform Healthcare in Guyana

19Labs | December 20, 2022

In cooperation with the Ministry of Health and the Georgetown Public Hospital Corporation a telemedicine pilot program with GALE eClinics was launched in four remote areas of Guyana. "We have reached a milestone and begin a journey that has the potential to transform health." Dr. Leslie Ramsammy, GPHC Board Chairman During the Telemedicine Launch, 19Labs CEO, Ram Fish, joined Guyana's Health Minister, Dr. Frank Anthony, in Masakenari, or as it is better known locally, Gunns Village. They were welcomed by the village Toshao, Paul Chekema, and the village residents. Using the newly installed eClinic system, Gunns was able to connect to the Georgetown Public Hospital and the three other villages that form part of this pilot program. The program's purpose is to provide equitable healthcare to all of Guyana's citizens. This keeps in line with the vision of Guyana's President, Dr. Ali, of creating a 'world-class' healthcare system for Guyana. Dr. Ramsammy, began the launch by saying: "Our ambition is to improve health care for all of our people, and as we understand that we can't put…a Georgetown public-level hospital in every village, we believe that citizens, in every part of the country, could get access to basic healthcare…We have reached a stage this morning, where we could launch Guyana's national telemedicine program." One of the major challenges in achieving such a vision is the remote locations with the lack of connectivity. Gunns Village is a 5-day boat and land trek during the rainy season when planes cannot use the local airstrip. 19Labs is proud to provide a solution as the four health posts that are part of this pilot are now connected to the world through the internet over satellite. With the GALE eClinic Telemedicine units, even the most isolated village now has access to top-quality medical care. In a very short time, Gunns went from an area that had no connectivity, electricity, and little medical equipment, to the ability to instantly connect to the healthcare and staff of the Georgetown Public Hospital. Dr. Anthony said: "With the technology we have now installed, this particular health center has a full complement of internet-enabled devices which we will…be able to do ultrasounds, ECGs, and a whole host of other things to help to assess the patient." GALE eClinics replicate the full clinical experience providing and filling the need for both general health and specialty care including prenatal, OBGYN, maternal, cardiac, and chronic condition management. Our partnership goes beyond a one-time fix. The local communities now have access to more opportunities. Ram Fish said: "This goes even beyond just health care, [this transforms communities]. The equity that it brings to us also opens the eyes of people and places to different cultures, and different ways of doing things…It's about empowering with technology local young women and men who really become the centers of the communities beyond just health…This is the beginning of a journey…We will expand and work together to really make healthcare equitable across Guyana and beyond." About 19Labs 19Labs is the creator of GALE, Next Generation Point-of-Care platform for pharmacies, schools, and rural communities. GALE brings together cutting-edge diagnostic technologies from industry leaders like Zoom, Elo, Amwell, Eko, Samsung Mobile, MIR, Omron, Viasat, and many others in one smart, efficient, and cost-effective platform. It was designed from the ground up to be operated by non-healthcare professionals, in locations with limited infrastructure and optimized for low bandwidth and intermittent connectivity.

Read More

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