Profitable milestones achieved and upcoming embody peer-reviewed publications, industrial agreements, and payer protection choices
Progressing with confirmed path towards normal of care addressing power low again ache, the most important expenditure in US healthcare costing Individuals an estimated $134 Billion yearly
Greater than $50 Million has been invested within the promising Aclarion AI platform that aids physicians in identification of painful discs
Expertise protected by 23 issued US patents, 17 issued worldwide patents, and 12 pending patent purposes
Three of 4 largest personal insurance coverage payers within the UK now protecting Nociscan
Partnership with ten outstanding KOL surgeons signed on to help Aclarion in efficiently gaining traction and reimbursement all through america
BROOMFIELD, CO, Sept. 12, 2024 (GLOBE NEWSWIRE) — Aclarion, Inc., (“Aclarion” or the “Firm”) (Nasdaq: ACON, ACONW), a healthcare know-how firm that’s leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to assist physicians establish the placement of power low again ache, at the moment offered a company replace. The replace opinions the profitable achievement of a number of current key milestones and supplies perspective on the optimistic implications of these catalysts because the Firm continues to ascertain Nociscan as a normal of care resolution assist software for the remedy of sufferers with power low again ache.
“We’re excited with the current optimistic success we have now been awarded as Aclarion has constantly achieved said catalysts of worth creation that fall into a really concise framework confirmed to convey disruptive technological developments to straightforward of care within the healthcare sector,” stated Brent Ness, CEO of Aclarion. “We intend to steer a optimistic diagnostic transformation in spine care by medical and financial proof that proves the promising worth of Nociscan. The constructing blocks we have now executed over the previous two years have just lately led to the achievement of our most vital catalyst so far which is a number of personal insurance coverage firms within the UK electing to pay for Nociscan. Payer protection is important to driving Nociscan to straightforward of care. We’re offering this company replace to share the method concerned in reaching this milestone, how that course of is being replicated at many websites all through the U.S., how we’re coordinating medical research in assist of cost, and why rising payer protection choices are important catalysts for driving the valuation of our firm. We’re clearly excited not solely by our current successes however much more so for our upcoming close to time period catalysts.”
The cornerstone of Aclarion’s technique to drive payer protection is to companion with Key Opinion Chief (KOL) physicians who see the worth of Nociscan of their follow and advocate for insurance coverage protection so the doctor can present higher care to extra sufferers. Aclarion now has a panel of 10 of the highest spine surgeon leaders on the earth aligned and actively talking on behalf of the efficacy and medical utility of including Nociscan to the analysis of sufferers that suffer from power low again ache. “These KOLs are collaborating within the assortment of medical knowledge, they’re participating insurance coverage firms and advantages administration entities to advocate for protection choices and representing Nociscan as an vital know-how worthy of societal endorsement,” stated Ryan Bond, Chief Technique Officer of Aclarion. “We imagine the standard of an organization’s KOL community is a direct reflection of the significance and promise of any new know-how and our checklist of KOLs is extra like that of a multibillion-dollar business chief than an rising know-how disruptor.”
Aclarion’s KOL advocacy technique utilized to the UK has led to nice success and is a mannequin of what the Firm expects to see replicated with their KOLs in america. Physicians within the UK initially got down to consider Nociscan know-how throughout 30 sufferers to find out if the know-how was useful. After evaluating Nociscan to invasive discography throughout solely 20 sufferers, the UK physicians noticed the worth of Nociscan and transformed their trial settlement right into a everlasting industrial settlement between Aclarion and The London Clinic, a serious supplier of spine care in London. As a part of that conversion, Aclarion was capable of safe elevated funds. To make sure a big phase of their sufferers would have unfettered entry to Nociscan, the UK KOLs, along side The London Clinic, then approached the most important personal medical health insurance suppliers within the UK for cost. Three of the highest 4 payers have now agreed to pay for Nociscan to date.
Payer protection choices like these achieved within the UK symbolize probably trajectory altering milestones as they pave the way in which for broad doctor adoption and predictable income. Aclarion is now including gross sales and advertising and marketing assets into London to speed up this adoption and the potential income inherent in these payer protection choices. The Firm is concurrently executing this similar physician-led technique all through america by its KOL panel.
To broaden entry to extra KOLs, Aclarion entered right into a strategic partnership with ATEC, a serious spine implant firm with a particular curiosity in leveraging pre-surgical knowledge to drive higher outcomes by its Alpha-Informatics platform. The partnership requires leveraging ATEC’s intensive doctor relationships to broaden Aclarion’s KOL advocacy technique to further surgeons.
In assist of its mission to drive Nociscan to straightforward of care, Aclarion has executed a number of industrial agreements offering entry to Nociscan at a number of MRI scanners in key markets reminiscent of New York, New Jersey, Arizona, Colorado, and Michigan. This groundwork will help in executing the strategic settlement in place with ATEC to judge using Nociscan with their KOLs. “We imagine within the significance of biochemical markers throughout the remedy paradigm and by partnering with Aclarion, we are able to progress towards a mutual goal to combine and advance applied sciences that enhance the predictability and reproducibility of spine affected person care,” said Pat Miles, CEO of ATEC.
The payer world consists of greater than normal industrial medical health insurance suppliers. Within the U.S., private injury and employee compensation instances make up a big a part of the low again ache market and the stakes of securing the fitting prognosis are extraordinarily excessive. On this market specifically, a premium is positioned on knowledge that’s objectively obtained and may help physicians decide one of the best remedy choices.
By partnering with Justin Kubeck, MD, an orthopedic spine surgeon in New Jersey, Aclarion is increasing into the non-public injury and staff compensation market with the identical physician-led technique that’s driving optimistic leads to London. Dr. Kubeck defined, “I’ll be main an effort to teach a discrete inhabitants of attorneys and judges who adjudicate PI and WC instances all through the state on the potential advantages of Nociscan for these excessive stake instances.”
For KOLs to be only in driving payers to cowl Nociscan, favorable medical and financial knowledge from medical trials is a vital requirement. Proof continues to mount in favor of using Nociscan to find out discogenic ache over the present invasive gold normal of provocative discography and for making remedy choices when provocative discography knowledge shouldn’t be obtainable.
The Firm was invited to take part within the Nationwide Institute of Health’s (NIH) Biomarkers for Evaluating Backbone Therapies (BEST) Trial which enrolled over 800 sufferers at 12 main tutorial instructing establishments throughout america, with a subset of 200 present process superior biomarker profiling, which included Nociscan. Outcomes from the trial are anticipated within the close to time period whereas the income produced from the trial has helped fund Aclarion’s march towards full industrial launch.
The Firm has revealed two peer reviewed journal articles based mostly on the outcomes of a pivotal research performed by Dr. Matt Gornet displaying that medical outcomes improved and had been sturdy after two years when Nociscan outcomes had been concordant with the surgical remedy of a affected person versus when surgical procedure didn’t comply with the Nociscan knowledge for figuring out painful discs. Bob Eastlack, MD said, “That is an outcomes outcome, not only a medical equivalency to a gold normal diagnostic research. Outcomes are what drive payer protection choices.”
To quantify the financial savings inherent in using Nociscan throughout the spine surgical procedure inhabitants of america based mostly on the conclusions of the Gornet research, the Financial Worth Evaluation of Low again ache (EVAL) evaluation was commissioned and executed by the Middle for Disruptive Musculoskeletal Improvements (CDMI). The outcomes of EVAL concluded that using Nociscan improves outcomes and reduces prices, conservatively saving the US healthcare system almost half a billion {dollars} yearly and by greater than $1,700 per affected person. EVAL was offered on the annual Worldwide Society for the Development of Backbone Surgical procedure (ISASS) assembly and at Backbone Week in Melbourne Australia. Backbone Week is a mixture of main spine societies that happens as soon as each 4 years. EVAL has been submitted for publication in a serious spine journal and Aclarion expects to announce that publication shortly.
Constructing on the medical success as evidenced by the Gornet research and the favorable financial evaluation of EVAL, the Firm has launched CLARITY, its flagship medical research. CLARITY is a potential, randomized, multi-center trial evaluating the outcomes of sufferers present process surgical procedure for power discogenic again ache when Nociscan is used within the decision-making course of versus when Nociscan shouldn’t be getting used within the decisioning course of. Primarily based on the outcomes of the Gornet Trial, Aclarion believes CLARITY will end in compelling knowledge that may quickly result in protection choices from each main insurance coverage supplier within the nation and endorsements from all the foremost spine societies. Nicholas Theodore, MD, FACS, FAANS, Director of Neurosurgical Backbone Middle, Johns Hopkins, and Professor of Neurosurgery, Orthopaedics and Biomedical Engineering is the Principal Investigator for CLARITY.
Extra compelling peer-reviewed knowledge has been revealed within the Worldwide Journal of Backbone Surgical procedure that highlights Nociscan as a Gold Customary for noninvasive identification for painful lumbar discs. The LIFEHAB trial continues to pay for using Nociscan within the 202-patient research as a key element of their analysis of surgical vs non-surgical remedy efficacy. The Firm expects to announce further sponsor-supported analysis research that generate further income.
Aclarion has expanded its IP place within the MR spectroscopy house and leads on each related entrance as a platform know-how that leverages MR spectroscopy and biomarker knowledge for the identification of painful discs. Over the previous two years, two key patents have been added. One to broaden our IP place when utilizing newer AI evaluation methods to research spectroscopy knowledge to establish biomarkers and one other to establish bacterial biomarkers related to ache.
Within the months forward, traders can depend on continued success in including peer reviewed proof publications, signing further industrial agreements, and most significantly, increasing optimistic payer protection choices.
For extra details about the BEST Trial, please go to: www.besttrial.org
For details about BACPAC, please go to: https://heal.nih.gov/analysis/clinical-research/back-pain
For extra details about REACH, please go to: www.bacpac-reach.org
About Aclarion, Inc.
Aclarion is a healthcare know-how firm that leverages Magnetic Resonance Spectroscopy (“MRS”), proprietary sign processing methods, biomarkers, and augmented intelligence algorithms to optimize medical remedies. The Firm is first addressing the power low again ache market with Nociscan, the primary, evidence-supported, SaaS platform to noninvasively assist physicians distinguish between painful and nonpainful discs within the lumbar spine. By means of a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) knowledge from an MRI machine for every lumbar disc being evaluated. Within the cloud, proprietary sign processing methods extract and quantify chemical biomarkers demonstrated to be related to disc ache. Biomarker knowledge is entered into proprietary algorithms to point if a disc could also be a supply of ache. When used with different diagnostic instruments, Nociscan supplies important insights into the placement of a affected person’s low again ache, giving physicians readability to optimize remedy methods. For extra data, please go to www.aclarion.com.
Ahead Wanting Statements
This press launch accommodates forward-looking statements throughout the that means of the Personal Securities Litigation Reform Act of 1995, Part 27A of the Securities Act of 1933 and Part 21E of the Securities Trade Act of 1934 in regards to the Firm’s present expectations about future outcomes, efficiency, prospects and alternatives. Statements that aren’t historic details, reminiscent of “anticipates,” “believes” and “expects” or related expressions, are forward-looking statements. These forward-looking statements are based mostly on the present plans and expectations of administration and are topic to a lot of uncertainties and dangers that would considerably have an effect on the Firm’s present plans and expectations, in addition to future outcomes of operations and monetary situation. These and different dangers and uncertainties are mentioned extra totally in our filings with the Securities and Trade Fee. Readers are inspired to overview the part titled “Threat Elements” within the Firm’s Annual Report on Kind 10-Ok for the 12 months ended December 31, 2023, in addition to different disclosures contained within the Prospectus and subsequent filings made with the Securities and Trade Fee. Ahead-looking statements contained on this announcement are made as of this date and the Firm undertakes no obligation to publicly replace or revise any forward-looking statements, whether or not because of new data, future occasions or in any other case.
Investor Contacts:
Kirin M. Smith
PCG Advisory, Inc.
646.823.8656
ksmith@pcgadvisory.com
Media Contacts:
Jodi Lamberti
SPRIG Consulting
612.812.7477
jodi@sprigconsulting.com
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