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Shiftwave and Lovell Announce Partnership to Increase Access to an Advanced Nervous System Regulation Device for VA, DoD

Shiftwave and Lovell Announce Partnership to Increase Access to an Advanced Nervous System Regulation Device for VA, DoD

Shiftwave and Lovell Partner to Bring Advanced Nervous System Regulation Technology to Federal Healthcare Providers
'Through our partnership with Shiftwave, we're bringing veterans a powerful tool to improve their health and recovery, ensuring they get the care they need and deserve.' — Chris Lovell, Major, USMC (Ret.), CEO of Lovell Government Services
PENSACOLA, FL, UNITED STATES, April 8, 2025 / EINPresswire.com / -- Lovell® Government Services and Shiftwave, a leading provider of the Shiftwave System, announced today that they have partnered to serve federal healthcare systems such as the Veterans Health Administration (VHA), the Military Health System (MHS), and the Indian Health Service (IHS). Lovell Government Services will serve as Shiftwave Service-Disabled Veteran-Owned Small Business (SDVOSB) vendor to serve these customers through federal contracting systems.
Shiftwave offers a nervous system recovery solution proven especially effective for military personnel, veterans, and first responders who routinely operate under stressful conditions. The portable system combines 18 microprocessor-controlled pulsed pressure wave drivers embedded in a zero-gravity chair with proprietary BioDrive® biofeedback technology. Shiftwave delivers targeted protocols that demonstrate remarkable efficacy in managing chronic pain, sleep disturbances, and stress-related conditions that traditional therapies can struggle to address effectively and as quickly.
As Shiftwave SDVOSB Vendor, Lovell is excited to bring this product to federal healthcare providers. Shiftwave is available on the Department of Veterans Affairs' Federal Supply Schedule (FSS), GSA Advantage, and the Defense Logistics Agency's Electronic Catalog (ECAT). Listing products on contract vehicles with Lovell streamlines the acquisition process while helping government agencies meet their SDVOSB procurement goals.
'Through our partnership with Shiftwave, we're bringing veterans a powerful tool to improve their health and recovery, ensuring they get the care they need and deserve.' said Chris Lovell, Major, USMC (Ret.), CEO of Lovell Government Services.
'Shiftwave was originally developed to enhance warfighter performance and resilience within U.S. Special Operations Forces,' said Mike North, Ph.D., Shiftwave CEO & Co-founder. 'Partnering with Lovell Government Services is an exciting step to ensure broader access across the VA and DoD, to provide advanced nervous system regulation technology that profoundly impacts the physical and mental readiness and recovery of those who serve our nation.'
About Shiftwave
Shiftwave is an innovative neurotechnology company that has emerged as a leader in the field of technology-enhanced nervous system regulation and recovery. The Shiftwave system has been field-tested in clinical settings and humanitarian applications, including Ukrainian military hospitals and rehabilitation centers.
Shiftwave is the world's most advanced nervous system regulation device that uses patented BioDrive® and Pulsed Pressure Wave technology to optimize your body's performance, reduce stress, improve focus, enhance sleep, reduce pain and boost overall vitality.
Created in a psychophysiology research lab and originally developed for the Special Operating Forces, Shiftwave is an official partner of the NFL Players Association, Exos and OneTeam. It's in use globally, from the NBA to the Premier League, from the Ukrainian frontlines to children's trauma camps, from firefighters to elderly care, and from the boardroom to bedtime for executives. Shiftwave has proven effective in the most challenging of situations, demonstrating that it can benefit anyone.
Lovell Government Services has been a trusted SDVOSB vendor since 2013 with a proven track record of successfully introducing suppliers to the government market. Lovell is a three-time Inc. 5000 honoree and leader in the federal space. They partner with medical and pharmaceutical companies looking to better serve Veteran and military patient populations, increase their federal revenue stream, and win government contracts.
Learn more at www.lovellgov.com
For Media Inquiries:
Ryan Camarra
Lovell Government Services
+1 850-466-3904
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Niagen Bioscience, Inc. Reports Second Quarter 2025 Financial Results and Increases Full Year Outlook
Niagen Bioscience, Inc. Reports Second Quarter 2025 Financial Results and Increases Full Year Outlook

Business Wire

time10 hours ago

  • Business Wire

Niagen Bioscience, Inc. Reports Second Quarter 2025 Financial Results and Increases Full Year Outlook

LOS ANGELES--(BUSINESS WIRE)--Niagen Bioscience, Inc. (NASDAQ:NAGE) today announced financial results for the second quarter of 2025. Niagen Bioscience, Inc. Reports Second Quarter 2025 Financial Results and Increases Full Year Outlook Share Second Quarter 2025 Financial Highlights Compared to Prior Year Period Total net sales increased 37% to $31.1 million, with Tru Niagen® sales reaching $22.7 million, growing 22%. Niagen® ingredient sales increased 135% to $7.4 million including food-grade and pharmaceutical-grade. Gross margin increased 480 basis points to 65.0%. Sales and marketing expense as a percentage of net sales was 26.4%, an improvement of 420 basis points. Net income of $3.6 million or $0.05 earnings per share, up from breakeven in prior year quarter. Adjusted EBITDA, a non-GAAP measure, increased 221% to $5.0 million. Total cash provided by operations of $9.1 million during the six months ended June 30, 2025, ending the quarter with $60.5 million in cash. Increased full year 2025 outlook: Net sales growth expected between 22%–27% (previously between 20%–25%), reflecting continued execution and leadership in the expanding NAD+ market. Recent Operational Highlights On June 9, 2025, the Company announced the publication of the first peer-reviewed clinical study of Niagen® in individuals with Werner syndrome, a rare premature aging disorder in Aging Cell. The 52-week randomized trial showed Niagen® significantly increased NAD+ levels and improved clinical markers of cardiovascular and skin health, supporting further investigation in rare, age-related diseases. On July 8, 2025, the Company entered into a worldwide exclusive license agreement with Haukeland University Hospital in Bergen, Norway, securing proprietary rights to develop and commercialize its patented nicotinamide riboside (Niagen®) as a potential pharmaceutical therapy for Parkinson's disease (PD). This agreement includes access to extensive clinical data, including from the Phase III NOPARK trial, and supports the Company's broader efforts to advance regulated therapeutic applications for neurodegenerative conditions. During June 2025, patient dosing the Phase III NOPARK trial was completed, the largest and most comprehensive clinical study of NAD+ augmentation in persons with early PD to date. NOPARK is a randomized, double-blind, placebo-controlled phase III clinical trial featuring 400 individuals with early-stage PD across 12 sites in Norway. Randomized to receive either 500 mg of nicotinamide riboside (Niagen) twice daily or placebo for 52 weeks, participants had follow-up assessments at five time points in a one-year period. The primary endpoint is the MDS-UPDRS total score, a gold standard measure of PD progression. Data analysis is underway and the data from this phase 3 trial is expected to be published in 2026. On July 14, 2025, the Company announced the launch of Tru Niagen® as an exclusive in-room amenity, and introduced Niagen IV at The Spa by Equinox Hotel New York through NutriDrip, marking Niagen Bioscience's entry into luxury hospitality. While featured at a single location, Equinox's sole hotel property, the launch aligns with a premium, health-conscious demographic and serves as a potential model for broader hospitality partnerships. As of August 2025, Niagen Plus products, including Niagen IV and injectables, are available in over 800 leading wellness clinics in the U.S., up from more than 475 clinics in December 2024. This growth reflects accelerating adoption by clinics and rising demand for clinically administered NAD+ solutions. Niagen Plus products are compounded and distributed through U.S. FDA-registered 503B outsourcing facilities and offered exclusively by prescription through participating wellness clinics. 'We delivered an excellent second quarter, with $31.1 million in net sales, up 37% year-over-year, and $3.6 million in net income,' said Niagen Bioscience CEO Rob Fried. 'As the pioneers of this blossoming NAD+ market, we continue to invest in the future while maintaining our focus on profitable growth." Results of operations for the three months ended June 30, 2025 compared to the prior year quarter Net Sales for Niagen Bioscience increased 37%, or $8.4 million, to $31.1 million. The growth in net sales was driven by combined growth in Tru Niagen® sales and Niagen® ingredient sales, including strong e-commerce channel performance, stronger demand for food-grade Niagen® and the ramp-up of pharmaceutical-grade Niagen® sales, which were not sold in the prior year quarter. Gross Margin improved 480 basis points to 65.0% primarily due to changes in product mix, business mix, the use of lower-cost inventory purchases, and improvements in labor and overhead utilization rates with higher sales. These gross margin improvements may not be indicative of future performance and certain drivers, such as lower-cost inventory purchases, are likely to be temporary in nature. Gross margins are expected to normalize in future periods. Operating Expense increased 22%, or $3.1 million, to $17.0 million reflecting investments for business growth and brand awareness. Selling and marketing expense increased $1.2 million, and improved 420 basis points as a percentage of net sales to 26.4% of net sales, reflecting improved sales efficiency and disciplined investment. The increase in expenses primarily reflects higher investments to support brand growth in our consumer products segment. General and administrative expense increased $1.6 million, or 28%, primarily driven by higher employee-related expenses, share-based compensation, and professional and consulting fees. Research and development expenses increased $0.3 million due to higher professional and consulting fees, as well as higher employee-related expenses. Net Income was $3.6 million, or $0.05 per share, compared to approximately break-even net loss and loss per share for the second quarter of 2024. Adjusted EBITDA, a non-GAAP measure, was $5.0 million, up from $1.6 million for the second quarter of 2024. See 'Reconciliation of Non-GAAP Financial Measures' for a reconciliation of non-GAAP Adjusted EBITDA to net income (loss), the most directly comparable GAAP measure. Cash Flows from Operating Activities had a net cash inflow of $9.1 million for the six months ended June 30, 2025 compared to approximately break-even cash flows in the prior year. The approximately $9.1 million increase in cash provided by operating activities was primarily driven by improvements in net income (loss), relatively higher collections on trade receivables, and a relative increase in accounts payable. These increases were partially offset by a decrease in credit loss expense due to a recovery of previously written-off amounts and higher inventory purchases associated with scaling our inventory reserves. 2025 Full Year Outlook Looking forward, for the full year, the Company is revising its revenue growth expectation from 20% to 25% year-over-year to 22% to 27%. This outlook reflects anticipated continued expansion of the Company's e-commerce business as well as growth through new and established partnerships. Gross margin is expected to improve slightly year-over-year compared to 61.8% in 2024, driven by ongoing supply chain optimization efforts, cost savings initiatives, and overall business scale. The Company is also updating its outlook for sales and marketing expenses. These costs are now expected to increase in absolute dollars compared to $29.5 million in 2024, but decrease as a percentage of net sales compared to 29.6% of net sales in 2024. This compares to the prior guidance of an increase in absolute dollars with a stable percentage of net sales year over year. The updated projection reflects the Company's continued strategic investments to enhance and strengthen brand awareness and support its various business channels while enhancing efficiencies. The Company remains committed to maintaining steady investments in research and development throughout 2025, with spending expected to align closely with fiscal year 2024 levels ($6.0 million), to continue driving future innovation. General and administrative expenses are expected to increase by approximately $7.0 to $8.0 million, primarily due to share-based compensation and investments in business growth and the absence of a $3.5 million royalty expense reversal that occurred in 2024. Investor Conference Call A live webcast will be held Wednesday, August 6, 2025 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss Niagen Bioscience's second-quarter financial results and provide a general business update. To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investors Relations section of Niagen Bioscience's website at The toll-free dial-in information for this call is 1-888-596-4144 with Conference ID: 8584242. The webcast will be recorded, and will be available for replay via the website from 7:30 p.m. Eastern time on August 6, 2025 through 11:59 p.m. Eastern time on August 13, 2025. The replay of the call can also be accessed by dialing 1-800-770-2030, using the Replay ID: 8584242. Important Note on Forward Looking Statements: This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as 'expects,' 'anticipates,' 'intends' 'estimates,' 'plans,' 'potential,' 'possible,' 'probable,' 'believes' 'seeks,' 'may,' 'will,' 'should,' 'could,' 'predicts,' 'projects,' 'continue,' 'would' or the negative of such terms or other similar expressions. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the quotation from Niagen Bioscience's Chief Executive Officer, statements related to the Company's 2025 financial outlook including but not limited to revenue growth, gross margin, expenses, investment plans, and the statements regarding Niagen Plus. Risks that contribute to the uncertain nature of the forward-looking statements include: inflationary conditions and adverse economic conditions; our history of operating losses; the growth and profitability of our product sales; our ability to maintain and grow sales, marketing and distribution capabilities; changing consumer perceptions of our products; our reliance on a single or limited number of third-party suppliers; risks of conducting business in China; including unanticipated developments in and risks related to the Company's ability to secure adequate quantities of pharmaceutical-grade Niagen in a timely manner; the Company's ability to obtain appropriate contracts and arrangements with U.S. FDA-registered 503B outsourcing facilities required to compound and distribute pharmaceutical-grade Niagen to clinics; the Company's ability to remain on the U.S. FDA Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Category 1 list; the Company's ability to maintain and enforce the Company's existing intellectual property and obtain new patents; whether the potential benefits of NRC can be further supported; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other governmental authorities; economic and market instability, including as a result of tariffs or trade conflicts; and the risks and uncertainties associated with our business and financial condition in general, described in our filings with the Securities and Exchange Commission (SEC), including, without limitation, our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q as filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and Niagen Bioscience undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. About Niagen Bioscience, Inc.: Niagen Bioscience is a global bioscience company dedicated to healthy aging. The Niagen Bioscience team, which includes world-renowned scientists, is pioneering research on nicotinamide adenine dinucleotide (NAD+), an essential coenzyme that is a key regulator of cellular metabolism and is found in every cell of the human body. NAD+ levels in humans have been shown to decline with age, among other factors, and may be increased through supplementation with NAD+ precursors. Niagen Bioscience is the innovator behind the NAD+ precursor nicotinamide riboside chloride ('NRC' commonly referred to as 'NR'), commercialized as the flagship ingredient Niagen®, available in both food and pharmaceutical grades. Nicotinamide riboside chloride and other NAD+ precursors are protected by Niagen Bioscience's patent portfolio. The Company delivers Niagen® as the sole or principal dietary ingredient in its consumer product line Tru Niagen® available at and through partnerships with global retailers and distributors. The Company also develops and commercializes proprietary-based ingredient technologies, including food-grade Niagen® and pharmaceutical-grade Niagen®, and supplies these ingredients as raw materials to the manufacturers of consumer products and U.S. FDA-registered 503B outsourcing facilities, respectively. The Company further offers natural product fine chemicals, known as phytochemicals, and related research and development services. Follow us on X (formerly Twitter) @NiagenBio and Instagram @TruNiagen and @NiagenPlus and subscribe to our latest news via our website accessible at to which Niagen Bioscience regularly posts copies of its press releases as well as additional updates and financial information about the Company. Niagen Bioscience, Inc. and Subsidiaries Unaudited Condensed Consolidated Balance Sheets (In thousands except par values, unless otherwise indicated) June 30, 2025 December 31, 2024 Assets Current assets: Cash and cash equivalents, including restricted cash of $152 for both periods presented $ 60,474 $ 44,660 Trade receivables, net of allowances of $199 and $95, respectively 9,656 7,768 Inventories 14,406 9,192 Prepaid expenses and other assets 2,143 2,482 Total current assets 86,679 64,102 Leasehold improvements and equipment, net 1,632 1,719 Intangible assets, net 284 359 Right-of-use assets 2,525 1,730 Other long-term assets 405 368 Total assets $ 91,525 $ 68,278 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 13,680 $ 8,526 Accrued expenses 7,381 7,817 Current maturities of operating lease obligations 957 982 Current maturities of finance lease obligations 6 12 Customer deposits 303 611 Total current liabilities 22,327 17,948 Deferred revenue 2,674 2,579 Operating lease obligations, less current maturities 2,329 1,657 Total stockholders' equity 64,195 46,094 Total liabilities and stockholders' equity $ 91,525 $ 68,278 Expand Niagen Bioscience, Inc. and Subsidiaries Unaudited Condensed Consolidated Statements of Cash Flows Six Months Ended June 30, (In thousands) 2025 2024 Net cash provided by / (used in): Operating activities $ 9,133 $ 31 Investing activities (167 ) (53 ) Financing activities 6,848 582 Net increase in cash and cash equivalents 15,814 560 Cash and cash equivalents beginning of period 44,660 27,325 Cash and cash equivalents at end of period $ 60,474 $ 27,885 Expand Niagen Bioscience, Inc. and Subsidiaries Unaudited Reconciliation of Non-GAAP Financial Measures Reconciliation of Net Income (Loss) to Adjusted EBITDA (In thousands) Q2 2025 Q1 2025 Q4 2024 Q3 2024 Q2 2024 Net income (loss), as reported $ 3,609 $ 5,063 $ 7,179 $ 1,878 $ (15 ) Adjustments: Interest income, net (552 ) (459 ) (373 ) (276 ) (241 ) Provision for income taxes 128 168 305 — — Depreciation 158 158 151 164 170 Amortization of intangibles 38 37 38 38 37 Noncash lease expense 159 173 169 164 163 Share-based compensation 1,488 1,075 752 735 1,185 Severance and restructuring 21 4 (4 ) 185 276 Reversal of previously accrued royalties and license maintenance fees (1) — — (3,521 ) — — Recovery of credit losses related to legal settlement (2) — (1,325 ) (1,325 ) — — Adjusted EBITDA $ 5,049 $ 4,894 $ 3,371 $ 2,888 $ 1,575 Expand (1) The reversal of previously accrued royalties and license maintenance fees related to a supplemental agreement with Dartmouth, which waived certain obligations under the exclusive license agreements. (2) The recovery of credit losses relates to the 2024 legal settlement with Elysium Health, LLC, paid in two installments, reversing a bad debt write-off from 2019. Expand Non-GAAP Financial Information: To supplement Niagen Bioscience's unaudited financial data presented in accordance with generally accepted accounting principles (GAAP), the Company has presented Adjusted EBITDA, a non-GAAP financial measure. Niagen Bioscience believes the presentation of this non-GAAP financial measure provides important supplemental information to management and investors and enhances the overall understanding of the Company's historical and current financial operating performance. The Company believes disclosure of the non-GAAP financial measure has substance because the excluded expenses are infrequent in nature, are variable in nature or do not represent current cash expenditures. Further, such non-GAAP financial measure is among the indicators the Company uses as a basis for evaluating the Company's financial performance as well as for planning and forecasting purposes. Accordingly, disclosure of this non-GAAP financial measure provides investors with the same information that management uses to understand the Company's economic performance year-over-year. Adjusted EBITDA is defined as net income (loss) before (a) interest, (b) provision for income taxes, (c) depreciation, (d) amortization, (e) non-cash share-based compensation costs, (f) severance and restructuring expense and (g) other infrequent items, including the reversal of previously accrued royalties and license maintenance fees, and the recovery of previously recognized credit losses from a legal settlement. While Niagen Bioscience believes that this non-GAAP financial measure provides useful supplemental information to investors, there are limitations associated with the use of such measure. This measure is not prepared in accordance with GAAP and may not be directly comparable to similarly titled measures of other companies due to potential differences in the method of calculation. Management compensates for these limitations by relying primarily on the Company's GAAP results and by using Adjusted EBITDA only supplementally and by reviewing the reconciliation of the non-GAAP financial measure to its most comparable GAAP financial measure. Non-GAAP financial measures are not prepared in accordance with, or an alternative for, generally accepted accounting principles in the United States. The Company's non-GAAP financial measure is not meant to be considered in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP.

Northwell's Staten Island University Hospital Performs First U.S. Procedure With New BioHealx Device for Complex Anal Fistulas
Northwell's Staten Island University Hospital Performs First U.S. Procedure With New BioHealx Device for Complex Anal Fistulas

Business Wire

time13 hours ago

  • Business Wire

Northwell's Staten Island University Hospital Performs First U.S. Procedure With New BioHealx Device for Complex Anal Fistulas

STATEN ISLAND, N.Y.--(BUSINESS WIRE)--Northwell's Staten Island University Hospital (SIUH) is the first medical center in the United States to perform surgery using the newly FDA-cleared BioHealx ®Anal Fistula Device - offering new hope to patients suffering from complex and often debilitating anal fistulas. The procedures were performed by colorectal surgeons Poppy Addison, MD, and Giovanni Bonomo, MD, director of colorectal surgery. The BioHealx device, developed by Irish-based Signum Surgical, represents a significant advancement in the treatment of complex anal fistulas, notoriously difficult to treat with current surgical options. The minimally invasive, absorbable implant is designed to close fistula tract as it traverses the anal sphincter complex, without involving any significant disruption of the anorectal anatomy. Early European data demonstrated an 84% success rate, far exceeding traditional approaches that often have success rates closer to 60% and are associated with the need for multiple procedures to finally achieve healing. 'Historically, these surgeries have been long, complex, traumatic to the anorectum and carried the risk of recurrence and incontinence,' said Dr. Bonomo. 'The BioHealx device is intuitive, efficient, and minimizes surgical trauma. If we can replicate the European outcomes, this could set a new standard of care in fistula treatment.' Approximately, 90,000 complex anal fistula procedures are performed yearly. These fistulas predominantly affect men between ages 18 and 50, and disrupts their quality of life due to anal pain, foul-smelling drainage, and recurrent infection. Fistulas can recur even after what appears to be healing at the skin level due to persistence of the transsphincteric fistula tract, and many patients undergo multiple interventions before finding relief. 'Rectal fistulas are under-researched and have lacked a reliable, standardized solution,' said Dr. Addison. 'This device has the potential to optimize care, shorten recovery, and reduce recurrence, all while preserving continence, which is a critical concern for our patients.' Before surgery, a seton drain is placed to help mature the fistula tract and to provide for clear identification of the internal fistula opening. During the BioHealx procedure, the seton is removed, the tract is brushed clean, and a small flap is created to expose the internal sphincter at the location of internal opening. The corkscrew-shaped BioHealx implant is then inserted to compress the tissue around the fistula tract as it traverses the width of the sphincter complex to deliver primary healing by direct tissue apposition. The flap is closed over the internal opening and internal anal sphincter, while the outer tract is partially opened for optimal drainage - all without damaging the sphincter muscle nor disrupting the anal canal. The implant itself is made from bioabsorbable polylactic glycolic acid and naturally dissolves in the body within six to twelve months, leaving no permanent material behind. The inspiration for the BioHealx device dates back to 2013 when engineers Eoin Bambury and Moshe Zilversmit, co-founders of Signum Surgical, met during a government-sponsored fellowship in Ireland. After observing the repeated failure of traditional surgeries to treat anal fistulas, often requiring four or more operations, they launched Signum Surgical in 2016 to develop a better solution. 'The key was identifying the failure of primary healing of the transsphincteric portion of the fistula tract as the root cause of surgical failure,' said Bambury. 'Our goal was to close it effectively without damaging the anal canal nor the anal sphincter. After years of research, clinical trials, and design refinement, we're proud to see our work helping patients here in the U.S.' SIUH's successful completion of the first U.S. procedures using the BioHealx device represents a critical milestone in the adoption of innovative, patient-centered technology across Northwell Health. 'Northwell has always championed advanced technologies that improve outcomes and quality of life,' said Dr. Bonomo. 'This is the kind of breakthrough that can change how we treat complex anal fistulas nationwide.' Drs. Bonomo and Addison will continue evaluating patient outcomes to help guide future adoption and research of the BioHealx procedure. With a shorter learning curve than many other surgical techniques, the team believes the procedure can be easily adopted across the entire system. 'We're incredibly optimistic,' said Dr. Addison. 'This device doesn't burn any bridges - it's safe, effective, and easy to use. If it doesn't work, patients still have all their future options with essentially normal anorectal anatomy. But if it does, it can spare them years of painful, frustrating treatments.'

ASP Introduces BIOTRACE™ Instant Read Steam System, Delivering Sterility Assurance in Just Seven Seconds
ASP Introduces BIOTRACE™ Instant Read Steam System, Delivering Sterility Assurance in Just Seven Seconds

Business Wire

time14 hours ago

  • Business Wire

ASP Introduces BIOTRACE™ Instant Read Steam System, Delivering Sterility Assurance in Just Seven Seconds

IRVINE, Calif.--(BUSINESS WIRE)--Advanced Sterilization Products (ASP), a global leader in infection prevention and sterilization solutions, is announcing the launch of the BIOTRACE™ Instant Read Steam System, the fastest FDA-cleared steam biological indicator system available in the U.S. Designed with sterile processing departments (SPDs) in mind, the new system delivers a readout in just seven seconds, drastically reducing wait time, minimizing errors, and enhancing clinical workflow efficiency. Current standard biological indicator systems can take 20 minutes or longer to generate a readout. BIOTRACE Instant Read Steam System changes the paradigm by offering SPDs the ability to verify sterilization results nearly immediately, which allows for faster decision-making, improved throughput, and reduced operational strain. In a hospital environment where every minute counts and every load matters, this technology enables confident, real-time transitions from sterilization to documentation. 'The launch of BIOTRACE Instant Read Steam System represents a significant advancement in our ability to deliver fast, actionable sterility data to frontline staff,' said Dr. Ivan Salgo, Vice President and Chief Medical and Scientific Officer at ASP. 'By reducing the readout time to just seconds, we're addressing a long-standing bottleneck that often impacts both productivity and peace of mind. This system supports SPDs not only in meeting compliance standards, but in exceeding them, with confidence.' Developed with advanced fluorescence detection, BIOTRACE Instant Read Steam System streamlines routine monitoring of steam sterilization cycles without compromising accuracy. The compact reader accommodates two simultaneous test positions, records the last 50 results, and connects seamlessly to digital infrastructure via USB, Wi-Fi, or Bluetooth®. Integration with the BIOTRACE™ Assist App and SM Cloud™ Web Application enables secure cloud storage, enhanced traceability, and automated reporting for hospital instrument tracking systems including CensiTrac™ and other major ITS software solutions. 'ASP is proud to lead the charge in redefining sterility assurance,' said Chad Rohrer, Global President of ASP. 'This is a leap forward in our commitment to help hospitals do more with less, supporting frontline staff with technology that empowers their work. The introduction of BIOTRACE Instant Read Steam System reinforces our role as a trusted partner in innovation for infection prevention, while elevating the standards of care and operational excellence.' A recent usability study confirmed that throughput and staffing remain top concerns in SPDs nationwide. Respondents cited a strong willingness to invest in time-saving technology, recognizing the value of immediate sterilization verification in high-pressure clinical environments. Hospitals and health systems can request demos and evaluation kits by contacting their ASP representative. About Advanced Sterilization Products (ASP) Advanced Sterilization Products (ASP), a Fortive company, is a global leader in infection prevention dedicated to safeguarding patients during their most critical moments. With a proven history of pioneering low-temperature sterilization and sterility assurance solutions, ASP delivers innovative technologies designed to raise the standard of care across healthcare settings. From terminal sterilization with hydrogen peroxide gas plasma to advanced steam monitoring tools, ASP supports healthcare facilities worldwide in improving efficiency, compliance, and patient safety. For more information, visit Advanced Sterilization Products (ASP) and Censis Technologies are subsidiaries of Fortive Corporation. CensiTrac™ software is a product of Censis Technologies. DISCLOSURE: The third-party trademarks used herein are the properties of their respective owners.

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