Linear Health Sciences LLC

OKLAHOMA CITY--( BUSINESS WIRE )-- Linear Health Sciences , a medical device company that has developed a proprietary, breakaway safety valve platform, today announced that it received an expanded indication for its Orchid Safety Release Valve (SRV) from the U.S. Food & Drug Administration (FDA). The Orchid SRV™ is a sterile, single-use connector for needle-free access that makes return to treatment fast, simple, and clean, and improves both the patient and clinician experience. It is indicated for patients two weeks of age and older during intermittent or continuous infusion, and can now be used during the transfusion of blood or blood products. “The Orchid SRV has been shown to significantly reduce IV dislodgement and its associated costs and complications,” said Rob Headley, vice president of sales and business development at Linear Health Sciences. “This, our third expanded indication, reflects a significant shift in the potential for a new gold standard of care, creates a valuable functional moat competitively, and expands our total addressable market exponentially.” The estimated 25 million U.S. dislodgement events, which are most frequently caused by patient confusion or removal of the catheter, loose dressing or tape, and/or tubing becoming tangled in bed linens, are projected to cost $2 billion annually. 1 “It’s crucial to protect IV access during blood administration for critical patients, to ensure a stable and uninterrupted flow of blood products, which can be life-saving,” said Jon Bell, MSN, RN, VA-BC, CEN, emergency department & cardiopulmonary services director at Mount Desert Island Hospital in Bar Harbor, Maine. “Orchid SRV can be used to safeguard the patient’s line even during blood administration, and is an innovative and valuable lifeguard for those who are already in a fragile condition.” Linear Health Sciences earlier this year was awarded a contract by the U.S. Dept. of Veterans Affairs (VA) for the Orchid device, in partnership with GS2. Additionally, more than a dozen clinical sites have evaluated Orchid, with clinical acceptance rates averaging more than 92 percent. A growing number of hospitals and healthcare systems are evaluating the device, recognizing their need for the expanded protection that the Orchid SRV can provide. One case study at a large, Northeast regional medical center showed annualized cost savings of nearly $104,000, and a clinical acceptance rate of more than 97 percent, leading to the whole-house adoption of the Orchid SRV. “Approval for blood transfusion is a huge step forward,” said Dennis Woo, RN, interventional vascular access specialist. “Reducing instances of catheter hub exchange for procedures as common as transfusion will greatly minimize exposure in the hematology/oncology population, while continuing to reduce risk of IV loss.” The Orchid SRV has also received an Innovative Technology contract from Vizient, Inc. , the nation’s largest member-driven healthcare performance improvement company, and was recently awarded a national group purchasing agreement for the IV Therapy - Needleless Connectors category with Premier, Inc . About Linear Health Sciences Linear Health Sciences is a medical device company that has developed a proprietary, breakaway safety valve technology designed to improve the use of medical tubing in hospitals. The platform technology was developed to increase the safety and satisfaction of patients, caregivers, and healthcare facilities, while dramatically reducing costs. The company’s initial products include the Orchid SRV for use in IV catheter therapy and the Orchid SRV Type D device for use in surgical/wound, nephrostomy and abscess drainage. For more information, visit linearsciences.com . ____________________ 1 Moreau, N. Impact and Safety Associated with Accidental Dislodgement of Vascular Access Devices: A Survey of Professions, Settings, and Devices. Journal of the Association for Vascular Access (2018) 23 (4): 203–215. https://doi.org/10.1016/j.java.2018.07.002

OKLAHOMA CITY--( BUSINESS WIRE )-- Linear Health Sciences , a medical device company that has developed a proprietary, breakaway safety valve platform, today announced that the Infusion Nurses Society (INS) has updated its standard of care to encompass devices designed to reduce the risk of vascular access device (VAD) dislodgement, including the Orchid SRV tension-activated breakaway safety release valve. The latest INS guidelines make products used to reduce the risk of VAD dislodgement due to the pulling/tugging of the administration set part of the standard of care, based on studies 1,2,3,4,5 showing that inadvertent VAD dislodgement is a clinically important problem for patients with VADs. The guidelines also flag pediatric patients and those with cognitive issues such as delirium or dementia as being at increased risk for IV dislodgement. The Orchid SRV is a sterile, single-use connector for needle-free access that makes return to treatment fast, simple, and clean, and improves both the patient and clinician experience. Clinical simulation testing of 360 Orchid SRVs showed that the device prevented IV dislodgement by 91.9 percent across all test groups. The device is placed between the existing IV extension set and general IV tubing connection intended to be used for delivery of fluids to and from an IV catheter. “Dislodgment of IV catheters is one of the most prevalent but least addressed issues in vascular care,” said Nancy L. Moureau, RN, PhD, BSN, CRNI, CPUI, VA-BC. “These new guidelines are a crucial development for increasing awareness about IV dislodgment in the field, and for helping reduce its negative impact on workflows, hospital costs, and patient care.” According to a study published in J-AVA , 95 percent of 1,561 U.S. clinicians surveyed agreed that IV dislodgement continues to pose safety risks for patients and hospitals. Of the 342 million peripheral IVs deployed in the U.S. each year 6 , up to 10 percent may dislodge 7 , costing more than $2 billion annually 8 . Dislodgement is most frequently caused by patient confusion or removal of the catheter, loose dressing or tape, or tubing becoming tangled in bed linens. “The INS decision is a critical step toward establishing vascular access safety devices, such as the Orchid SRV, as the gold standard of IV care, demonstrating the great clinical need for reducing IV dislodgement – particularly for pediatric patients and those with cognitive impairment,” said Dan Clark, co-founder and CEO of Linear Health Sciences. “The decision is also an important validation of the entire product category.” The Orchid SRV has received an Innovative Technology contract from Vizient, Inc. , the nation’s largest member-driven healthcare performance improvement company, recently awarded a national group purchasing agreement for the IV Therapy - Needleless Connectors category with Premier, Inc ., and received a Federal Supply Schedule with VA/Dept. of Defense access from the U.S. Dept. of Veterans Affairs. About Linear Health Sciences Linear Health Sciences is a medical device company that has developed a proprietary, breakaway safety valve technology designed to improve the use of medical tubing in hospitals. The platform technology was developed to increase the safety and satisfaction of patients, caregivers, and healthcare facilities, while dramatically reducing costs. The company’s initial products include the Orchid SRV for use in IV catheter therapy and the Orchid SRV Type D device for use in surgical/wound, nephrostomy and abscess drainage. For more information, visit linearsciences.com . ____________________ 1 Balmforth JE, Thomas AN. Unplanned removal of medical devices in critical care units in North West England between 2011 and 2016. Am J Crit Care. 2019;28(3):213-221. doi:10.4037/ajcc2019961 2 Galazzi A, Adamini I, Consonni D, et al. Accidental removal of devices in intensive care unit: an eight-year observational study. Intensive Crit Care Nurs. 2019;54:34-38. doi:https://doi.org/10.1016/j. iccn.2019.06.002 3 Indarwati F, Mathew S, Munday J, Keogh S. Incidence of peripheral intravenous catheter failure and complications in paediatric patients: systematic review and meta analysis. Int J Nurs Stud. 2020;102:103488. doi:10.1016/j.ijnurstu.2019.103488 4 Moureau N. Impact and safety associated with accidental dislodge- ment of vascular access devices: a survey of professions, settings, and devices. J Assoc Vasc Access. 2018;23(4):203-215. doi:10.1016/j. java.2018.07.002 5 Sapko MT. PICC lines-waterproofing & securement on neonates. Neonatal Intensive Care. 2020;33(1):38-39. 6 iData research report 7 "The Peripheral Intravenous Catheter Journey: A Prospective Cohort Study of 1000 Patients." Podium presentation 8 Helm, et al. “Accepted but unacceptable: peripheral IV catheter failure” J Infus Nurs May-Jun 2015;38(3):189-203. doi: 10.1097/NAN.0000000000000100

OKLAHOMA CITY--(BUSINESS WIRE)--Linear Health Sciences has been awarded a national group purchasing agreement for the IV Therapy - Needleless Connectors category with Premier, Inc. Effective Jan. 1, 2024, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for the Orchid SRV force-activated separation device. “This early recognition from Premier is another indication of the value of our platform for breakaway safety release valve technologies to patients, clinicians, and healthcare providers,” said Dan Clark, co-founder, president, and COO of Linear Health Sciences. “Orchid SRV’s proven impact on quality outcomes can now be extended across the Premier alliance’s user base.” The Orchid SRV is a sterile, single-use connector for needle-free access that, when activated, makes return to treatment fast, simple, and clean, while improving both patient and clinician experiences. The device is placed between the existing IV extension set and general IV tubing connection intended to be used for delivery of fluids to and from an IV catheter. Clinical simulation testing of 360 Orchid SRVs showed that the device prevented IV dislodgement by 91.9 percent across all test groups. According to a study published in JAVA, the vast majority of U.S. clinicians surveyed agreed that IV dislodgement continues to pose safety risks for patients and hospitals. In fact, reports have shown that, of the 342 million peripheral IVs in the U.S. each year,1 up to 10 percent may dislodge,2 costing more than $2 billion annually.3 Premier is a leading healthcare improvement company, uniting an alliance of approximately 4,350 U.S. hospitals and 300,000 other providers to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, consulting and other services, Premier enables better care and outcomes at a lower cost. About Linear Health Sciences Linear Health Sciences is a medical device company that has developed a proprietary, breakaway safety valve technology designed to improve the use of medical tubing in hospitals. The platform technology was developed to increase the safety and satisfaction of patients, caregivers, and healthcare facilities, while dramatically reducing costs. The company’s initial products include the Orchid SRV for use in IV catheter therapy and the Orchid SRV Type D device for use in surgical/wound, nephrostomy and abscess drainage. For more information, visit linearsciences.com. ___________________ 1 iData research report 2 "The Peripheral Intravenous Catheter Journey: A Prospective Cohort Study of 1000 Patients." Podium presentation by Nicole Marsh, RN, and Claire Rickard, RN, PhD, AVA 2017 annual meeting 3 Helm, et al. “Accepted but unacceptable: peripheral IV catheter failure” J Infus Nurs May-Jun 2015;38(3):189-203. doi: 10.1097/NAN.0000000000000100