BCWORLD PHARM. Co., Ltd.

BALTIMORE--( BUSINESS WIRE )--ReGelTec, Inc. (ReGelTec) announced that it has entered into an agreement with BCWorld Healthcare Co., Ltd. (BCWH) that provides BCWP exclusive rights to distribute the HYDRAFIL™ System for the treatment of Chronic Low Back Pain (CLBP) due to Degenerative Disc Disease (DDD) in the South Korean market. The agreement includes an investment by BCWH in ReGelTec. BCWH will also fund a clinical study in South Korea to support regulatory approval from the Ministry of Food and Drug Safety (MFDS) with ReGelTec providing HYDRAFIL™ Systems for the study. The companies have already started planning regulatory strategies for approval and expect the trial to begin in 2024. HYDRAFIL™ is a hydrogel that is heated and injected into a disc using a fine gauge needle during a minimally-invasive outpatient procedure. The injected hydrogel augments the degenerated nucleus and fills in cracks and tears to help restore natural biomechanical properties while preserving spinal motion and relieving pain. The device received breakthrough device designation in 2020 from the Center for Devices and Radiological Health of the Food and Drug Administration (FDA). More than sixty people have been treated with HYDRAFIL™ in clinical studies in Barranquilla and Cali, Colombia, and in Calgary, Canada with promising clinical results out to 2-years in the initial cohort patients. “We are excited to secure the rights to distribute the HYDRAFIL™ System in South Korea,” said Steve Hong, CEO and President of BCWH. “This is meaningful as it is our first investment in a private company, and is our first step to expand into the medical device arena and diversify our product offerings beyond the current business model.” Once regulatory approval is obtained, the HYDRAFIL™ System will be added to pain management products that BCWH and its parent company BCWorld Pharm. Co., Ltd. offer to pain physicians. “The HYDRAFIL™ System will be a milestone to entry into innovative business aligning with our mission, ‘commit to a better future for patients.’” said Steve Hong. “We are always looking for strategic partners that can help us expand the reach of the HYDRAFIL™ System,” said Bill Niland, ReGelTec’s co-founder and CEO. “Now that we have 2-year follow-up data on initial patients and 1-year follow-up on the first 60 patients treated with HYDRAFIL™, we know that the technology has the potential to transform the treatment of CLBP due to DDD. Our partnership with BCWH will also help the company generate additional clinical evidence to demonstrate the safety, efficacy, and economic impact of the HYDRAFIL™ System.” About BCWH: Founded in 2017, BCWorld Healthcare Co., Ltd. (“BCWH”) is a subsidiary of BCWorld Pharm. Co., Ltd., a Korean pharmaceutical company with expertise in drug development, especially for long-acting injectables and orally disintegrating tablets. BCWH has built the first MFDS-approved, carbapenem-dedicated manufacturing facility in Korea and is leading the supply of antibiotics in the domestic market and pursuing to expand their territories to the global market. Beyond BCWorld Pharm., BCWH plans to accelerate its business diversification plan to discover innovative healthcare products, including pharmaceuticals, digital therapeutics, and customized health functional food. ABOUT REGELTEC, INC: ReGelTec, Inc. is a clinical stage medical device company commercializing HYDRAFIL™, a percutaneous treatment for low back pain due to degenerative disc disease. The company was formed when a team of chemical engineers with extensive experience in polymer science partnered with a cross-functional team of medical device professionals with multiple successful startup exits. Once approved, the HYDRAFIL™ System will offer patients suffering from chronic back pain due to degenerative disc disease a minimally invasive treatment option beyond traditional conservative care. HYDRAFIL™ is an investigational device, limited by United States law to investigational use.

None By Dr. Sean Kelly, Chief Medical Officer at Imprivata Put yourself in my shoes… a Code Stroke patient arrives in our busy ER. Time is of the essence. We need to rapidly diagnose and treat the patient to prevent long term paralysis or even death. But nothing happens until we can access their health records, review the relevant data, order a CT scan, consult our colleagues, and initiate treatment. And none of that can happen at all because our hospital has put in a new enhanced password policy. As well they should. Keeping protected health information (PHI) private and secure is of utmost concern in healthcare…but more on that later. Right now, there’s a patient in need and I’ve fat-fingered my “17 character, must include a number and a special character, that can’t have repeating characters or be similar to any prior passwords, and changes every four months” password. Which happens a lot, obviously.  Or I’ve forgotten it. And now I’m locked out of the system. No CT scans. No life-saving drugs. Unless I use a colleague’s password to get in... What to do? The battle between security and usability has long been a problem in healthcare. The workflow is extremely complex - with hundreds of users in different roles, often using shared workstations that become as busy as hummingbird feeders. Fast-user switching is integral to the workflow, as clinicians must access a dizzying array of health records and applications during a shift. Despite seeming secure, long, complex passwords result in an inordinate amount of time wasted, frustration, delays in care, and staff burnout. And with so many that are difficult to remember, many users have to write them down or store them on a device - making them vulnerable to a breach anyhow. This isn’t an uncommon predicament for healthcare workers: either spend more time logging into the EHR, or workaround the process to have quicker access. Technology was meant to enable healthcare, yet, in many aspects, it’s become a hindrance.  So, what can we do? Security can’t be ignored. The stakes are higher in healthcare A cybersecurity breach could take down an entire network, sending a delicate workflow into chaos and putting patients and PHI in a dangerous situation. A recent survey found that 32% of HDOs reported they had to divert patients to alternative healthcare facilities after a cyberattack, with 31% experiencing delayed procedures that resulted in poor patient outcomes. The volume and frequency of healthcare data breaches has nearly doubled in the last three years, making it clear that HDOs need to change their approach. The stakes are higher for healthcare, and the industry cannot afford to ignore this problem. But what if we didn’t have to choose between security and compliance on one hand, and usability, and efficiency on the other? What if we could get more of both by giving up traditional complex passwords and perimeter security?  Rather, HDOs should implement a digital identity strategy to improve patient care and balance efficiency with security. As budgetary challenges plague the industry, investing in resilient solutions is critical. The digital identity solution Because digital identity focuses on securing the user and their credentials rather than the perimeter, it enables frictionless authentication, leveraging technology like proximity cards, secure low energy Bluetooth,  or biometric modalities like fingerprints, palm veins or facial recognition. When utilized for password-less single sign-on, clinicians see reduced logins. This enables security and compliance while improving clinical productivity and patient care. This is a win-win-win for the clinician, patient, and the IT security team. “We hire thousands of people every year,” said Cletis Earle, CIO of PennState Health. “If you consider the fully burdened cost of an employee, assume each employee loses a couple hours productivity per day during their first couple weeks on the job, and do the math, the lost productivity costs are substantial.” With over 15 minutes spent logging into the EHR per patient, this is time that no clinician can afford to lose.  The cost savings, reduced risk, and improved clinician quality of life are substantial with this approach. Enabling the future of healthcare Traditional security causes workarounds that introduce risk and slow down patient care. It’s time for healthcare to modernize their IT strategy. Digital identity is becoming more widely adopted across the industry and should be viewed as the key to protecting medical information, ensuring proper access, and optimizing efficiency. As healthcare organizations confront budgetary challenges and cyber threats in the year ahead, it’s important to consider the long-term benefits of identity-centered security. Ensuring future tools are helpful requires them to be accessible. Trust me, the next time you or a loved one ends up in the ER, you will want the clinical staff to have safe, secure, and efficient access to your records. Digital identity is the key to this success.     Author: Dr. Sean Kelly, Chief Medical Officer and SVP Customer Strategy, Healthcare Bio: Dr. Sean Kelly is the Chief Medical Officer (CMO) and Sr. VP of Customer Strategy for Healthcare at Imprivata, where he leads the company’s Clinical Workflow team and advises on the clinical practice of healthcare IT security.

SEATTLE--( BUSINESS WIRE )-- Monod Bio , a life sciences company developing custom diagnostic biosensors that emit light to detect specific analytes of interest, today announced a publication in Nature highlighting its LuxSit de novo luciferase technology licensed from the University of Washington (UW). As reported in the journal Nature, a team based at the Institute for Protein Design (IPD) at UW Medicine devised machine-learning algorithms that can create light-emitting enzymes called luciferases. Laboratory testing confirmed that the new enzymes can catalyze specific chemicals and emit light very efficiently. For the first time, scientists used machine learning to create brand-new enzymes, an important step in the field of de novo protein design, as new enzymes could have many uses across medicine and industrial manufacturing. To create new luciferase enzymes, the team first selected chemicals called luciferins that they wanted the proteins to act upon. They then used software to generate thousands of possible protein structures that might react with those chemicals. The luciferase technology (LuxSit) developed by the Institute of Protein Design (IPD) at the University of Washington School of Medicine, researchers and licensed by Monod Bio, a Seattle based biotech company that uses state-of-the-art computational protein design to develop a new class of modular biosensors that emit a bioluminescent signal when the sensor recognizes its target. Biosensors are molecular tools that detect the presence of specific molecules, even at very low concentrations. Monod's biosensors are built from de novo engineered proteins developed in part using software from the (IPD). Combining these biosensors with the de novo luciferases will create new commercial opportunities for Monod Bio. “I am thrilled that Monod Bio will be advancing LuxSit for its use in life sciences. This is just the first example of what we can now achieve using de novo proteins for biosensors and diagnostics,” said senior author David Baker, Ph.D., the Henrietta and Aubrey Davis Endowed Professor of Biochemistry at the University of Washington School of Medicine, a Howard Hughes Medical Institute investigator, Co-Founder of Monod Bio, and the Founder and Director of IPD. “We were able to design very efficient enzymes from scratch on the computer, as opposed to relying on enzymes found in nature. This breakthrough means that custom enzymes for almost any chemical reaction could, in principle, be designed,” said Andy Yeh, Ph.D., Scientific Co-Founder at Monod Bio and first author on the paper. “LuxSit and its underlying de novo protein design technology are fundamental to what we are developing at Monod Bio. With our expertise and resources we are uniquely positioned to fully unlock its potential to develop new biosensors and many other industry applications,” said Daniel-Adriano Silva, Ph.D., CEO & Co-Founder, Monod Bio. “We continue using LuxSit, machine learning, and de novo protein design to advance our unique biosensor pipeline aimed to improve human health. We look forward to announcing further details on our progress with the LuxSit platform later this year.” About Monod Bio Monod Bio is a pioneering company in the design of de novo protein-based biosensors that emit light when they recognize an intended target. The Company’s innovative biosensor platform technology uses computational de novo protein design to create highly modular biosensing nanoswitches that enable rapid, sensitive, and cost-effective analytical assays. The company is founded on technology developed in David Baker’s group at the University of Washington’s Institute for Protein Design, including the LucCage biosensor platform and the LuxSit de novo luciferase technology. Monod Bio's proprietary technology has been published in several peer-reviewed journals, including Nature and Nature Biotechnology , expanding our understanding of what is possible with de novo protein biosensors. Monod Bio is based in Seattle, WA. For additional information, visit www.monodbio.com .