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ONWARD Medical

Develops ARC Therapy for spinal injury

Overview

ONWARD Medical develops ARC Therapy, an investigational neurostimulation technology aimed at restoring movement for people with spinal cord injuries. The system uses targeted, programmed stimulation of the spinal cord to re-enable locomotion and may also improve bladder control, sexual function, and blood pressure. The company does not yet sell the device; it licenses its intellectual property and works with leading research institutions to advance its therapy. Unlike many competitors, ONWARD focuses on a proprietary spinal cord stimulation approach and a licensing-based business model built on strong academic partnerships. The ultimate goal is to obtain regulatory approval and commercialization of ARC Therapy to improve outcomes for patients with spinal cord injuries and support healthcare providers and institutions treating them.

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About ONWARD Medical

Simplify's Rating
Why ONWARD Medical is rated
B-
Rated B on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

Industries

Robotics & AutomationBiotechnologyHealthcare

Company Size

201-500

Company Stage

IPO

Headquarters

Eindhoven, Netherlands

Founded

2014

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What believers are saying

  • Q3 2026 ARC-EX unit volume reached 88, up 120% year over year.
  • BlackRock funding added €20M in October 2026, extending runway and retiring Runway Growth Capital.
  • ARC-EX expanded to 170+ clinics worldwide, including 150 U.S. rehabilitation and VA facilities.

What critics are saying

  • Q3 2026 revenue was only €2.5M, leaving ONWARD dependent on financing until 2028.
  • ARC-IM remains investigational; EIGER and Empower BP can fail, delaying commercialization past 2027.
  • Home-use reimbursement is slow; VA evaluation extensions already push ARC-EX revenue into 2027.

What makes ONWARD Medical unique

  • ARC-EX is the first FDA-cleared non-invasive SCI device, now in 170+ clinics.
  • Up-LIFT in Nature Medicine showed 90% of patients improved strength or function.
  • ONWARD combines ARC-EX revenue with ARC-IM, BCI, and blood-pressure programs.

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Funding

Total Funding

$408.8M

Above

Industry Average

Funded Over

14 Rounds

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Growth & Insights and Company News

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Good Shepherd Rehabilitation Network
Nov 3rd, 2026
Good Shepherd Rehabilitation introduces revolutionary non-invasive treatment for people with spinal cord injury.

Good Shepherd Rehabilitation introduces revolutionary non-invasive treatment for people with spinal cord injury. Allentown, Pa. - Good Shepherd Rehabilitation today announced the acquisition of the groundbreaking ARC-EX System from ONWARD Medical, becoming the first facility in eastern Pennsylvania to offer this FDA-cleared therapy for people with chronic spinal cord injuries (SCI). The ARC-EX System is the first FDA-cleared non-invasive technology clinically proven to improve hand strength and sensation for individuals with SCI. This milestone represents a new era of hope for the SCI community, who previously had limited options for functional recovery after their injury. "This technology represents a significant advancement in our ability to help people with spinal cord injuries regain function and independence," said Good Shepherd Chief Medical Officer and Senior Vice President of Medical Affairs Sandeep Singh, MD, FAAPMR. "With this system, we can go beyond conventional rehabilitation approaches and directly address the neurological challenges of spinal cord injury." The ARC-EX System was selected as a TIME Magazine Best Invention in 2024 and has received FDA Breakthrough Device designation. Good Shepherd acquired the device through funding provided by the Fleming Foundation, which in 2023 partnered with Good Shepherd to establish The Fleming Center for Robotics in Rehabilitation, a forward-thinking hub designed to identify and test robotic and wearable technology to further provide leading-edge rehabilitation care, and ultimately, contribute to the future of rehabilitation. How the ARC-EX system works. The ARC-EX System delivers programmed electrical stimulation through the skin to the spinal cord via electrodes placed on the back of the neck. This non-invasive approach requires no surgery. During therapy sessions, people with SCI use the device while performing functional tasks guided by trained rehabilitation specialists. Designed for clinical use, the system supports up to one hour of daily therapy and complements specialized rehabilitation exercises. The Up-LIFT clinical study published in Nature Medicine showed that 90% of participants improved in upper limb strength or function, with 87% reporting enhanced quality of life. Additional benefits included reduced spasm frequency, improved sleep quality, and better upper body sensation. Regaining hand function is consistently rated as the highest treatment priority for people with spinal cord injuries, as it directly impacts independence in daily activities like eating, dressing, and personal care. Good Shepherd patients have experienced increased functional use and dexterity of their fingers and hands, and other functional improvements. Walter Jakovlevs, a spinal cord injury patient at Good Shepherd, utilizes the ARC-EX System in both physical and occupational therapy. "I have definitely noticed more movement in my fingers," he said. The ARC-EX System is available at Good Shepherd for individuals with chronic, non-progressive spinal cord injuries (C2-C8 inclusive) who are between 18 and 75 years old. People with SCI interested in learning more about the ARC-EX system and how to get started can contact Good Shepherd Rehabilitation's Physician Group at 610-776-3278 or contact Good Shepherd online. Photo Caption: A person utilizes the ARC-EX System to stack plastic pieces on top of each other (Credit: ONWARD Medical). About Good Shepherd Rehabilitation. Good Shepherd Rehabilitation, an independent, not-for-profit rehabilitation network with 1,300 employees and nearly 30 locations in eight counties of eastern Pennsylvania, is committed to transforming the lives of people of all ages and abilities through curiosity, creativity, expertise and innovation. Headquartered in Allentown, Pennsylvania, Good Shepherd Rehabilitation specializes in treatment of spinal cord injury, brain injury, stroke, major multi-trauma, autism and neurodevelopmental diagnoses, pulmonary disease, respiratory failure, musculoskeletal/orthopedics and complex pediatric conditions. Info: www.goodshepherdrehab.org or 1-888-447-3422 (44-REHAB) About ONWARD Medical and the ARC-EX System. ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries, and other movement disabilities. Building on over a decade of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company developed ARC Therapy. It has subsequently been awarded 10 Breakthrough Device designations from the FDA. The Company's ARC-EX(R) System is cleared for commercial sale in the US. The Company is also developing an investigational implantable system called ARC-IM, which can be paired with a brain-computer interface (BCI) to restore thought-driven movement. Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD) and its US ADRs can be traded on OTCQX (ticker: ONWRY). For more information, please visit ONWD.com.

Yahoo Finance
Nov 3rd, 2026
ONWARD Medical posts $2.8M Q3 revenue as ARC-EX unit sales rise 120%

ONWARD Medical reported third-quarter 2026 revenue of €2.5M and a cash balance of €73.4M as of September 30, 2026. The Dutch neurotechnology company said €2.0M of revenue came from ARC-EX systems. It sold or supplied via paid evaluation 88 ARC-EX systems, up 120% from a year earlier. The therapy, which improves hand strength and sensation after spinal cord injury, is now offered in more than 170 clinics worldwide. In its Empower BP pivotal study of the ARC-IM system, 31 participants are enrolled across 16 active sites in the US, Canada, and Germany. During the quarter, the company secured a financing agreement of up to €50M with BlackRock-managed funds and drew €20M to repay its former lender, Runway Growth Capital.

GlobeNewswire
Nov 3rd, 2026
ONWARD Medical delivers revenue of EUR 2.5M in Q3 2026, with sustained commercial momentum and strong clinical execution.

ONWARD Medical delivers revenue of EUR 2.5M in Q3 2026, with sustained commercial momentum and strong clinical execution. EINDHOVEN, the Netherlands, Nov. 03, 2026 (GLOBE NEWSWIRE) - ONWARD Medical N.V. (Euronext: ONWD - US ADR: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI) and other movement disabilities, today announces its results for the third quarter of 2026 with a comprehensive business update: * Financial highlights: The Company reported EUR 2.5M in Q3 revenue and a cash balance of EUR 73.4M as of September 30, 2026. * Commercial traction: 88 ARC-EX(R) Systems were sold or supplied via paid evaluation in Q3, a 120% year-over-year growth in units. At the end of the quarter, ARC-EX was available in more than 170 clinics worldwide, including 150 rehabilitation clinics and Veterans Affairs (VA) facilities in the US. * Empower BP global pivotal study: The Company continued to advance the Empower BP study, with 31 participants enrolled to date and 16 clinical sites actively recruiting across the US, Canada, and Germany. * Clinical milestones: The Company advanced several clinical feasibility studies exploring future indications for investigational ARC-IM(R) Therapy. Key milestones included the first subacute implant in the EIGER clinical feasibility study evaluating ARC-IM Therapy to restore mobility after SCI; the first-in-human use of ARC-IM Therapy to restore bladder control after SCI; and two additional implants in an ongoing feasibility study addressing blood pressure instability in Parkinson's disease. "We continue to drive strong execution across our commercial and clinical priorities while maintaining financial discipline. Access to ARC-EX is expanding worldwide, helping more people with spinal cord injury improve hand strength and sensation. We are also advancing our therapy pipeline through Empower BP, the first global pivotal study of our ARC-IM platform, and meaningful progress across our clinical feasibility programs," said Dave Marver, CEO of ONWARD Medical. "Building on three quarters of strong execution and a healthy balance sheet, we are well positioned to advance our strategic priorities through the remainder of the year." Commercial traction In Q3, the Company sold or supplied via paid evaluation 88 ARC-EX Systems for use in clinics and homes. Quarterly unit volumes more than doubled year over year. ARC-EX Therapy is now available in more than 170 clinics worldwide, including 150 US rehabilitation clinics and US Veterans Affairs facilities. A growing number of rehabilitation clinics outside the US also offer ARC-EX, including in the Netherlands, Switzerland, Germany, UK, France, Israel, Italy, and Spain. The majority of ARC-EX systems supplied in Q3 were intended for home use. Expansion into the home addresses the demand for broader and more convenient access to ONWARD's groundbreaking technology, which is indicated to improve hand strength and sensation after SCI. In the US, home use adoption was driven by self-pay, 90-day paid evaluations within the VA, VA purchases, and individuals who pursued reimbursement from private insurers on a case-by-case basis. Empower BP global pivotal study The Company continues to make steady progress in the execution of Empower BP, the first global pivotal study designed to assess the safety and effectiveness of the investigational ARC-IM System to manage blood pressure instability in people with SCI. The randomized, double-blind, sham-controlled study involves leading neurorehabilitation and neurosurgical research centers across North America and Europe. To date, 31 participants have been enrolled in Empower BP, with 16 clinical sites actively recruiting across the US, Canada, and Germany. Pipeline advancement Following the initiation of the EIGER clinical feasibility study to evaluate the investigational ARC-IM System for restoring mobility after spinal cord injury, the Company reported first implants in both the chronic and subacute cohorts. EIGER is the first ONWARD mobility study to include individuals with subacute SCI, defined as injuries sustained within six weeks of enrollment. The study is being conducted in Switzerland at the Schweizer Paraplegiker-Zentrum (SPZ) in Nottwil and the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, with the support of a grant from Innosuisse. The Company also achieved the first-in-human use of investigational ARC-IM Therapy to explore its potential to restore bladder control after SCI as part of ReeVoid, a new clinical feasibility study. ReeVoid is designed to evaluate the safety and preliminary effectiveness of targeted spinal cord stimulation to improve bladder emptying and urinary continence after SCI. The study is being conducted at CHUV in Lausanne and is supported by a grant from the Christopher and Dana Reeve Foundation. The Company made further pipeline progress with two additional participants receiving investigational ARC-IM Therapy as part of an ongoing early clinical feasibility study focused on addressing blood pressure instability associated with Parkinson's disease. This study is supported by a grant from the US Department of Defense Parkinson's Research Program. Financial highlights The Company reported EUR 2.5M in total revenue for the quarter. Revenue from the sale and supply of ARC-EX systems was EUR 2.0M. As of September 30, 2026, the cash balance was EUR 73.4M, in line with expectations. In Q3, the Company secured a financing agreement for up to EUR 50M with funds and accounts managed by BlackRock. An initial EUR 20M was drawn at closing to fully repay all outstanding amounts and retire the Company's former financing agreement with Runway Growth Capital LLC. Corporate governance In October, the Company announced the appointment of Fouad Azzam, a Partner in the EQT Life Sciences team, as a non-executive member of its Board of Directors. Webcast details ONWARD Medical will hold a webcast today, November 3, 2026, at 2:00 p.m. CET / 8:00 a.m. ET, hosted by CEO Dave Marver. To join the session, please register using this link. About ONWARD Medical ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries and other movement disabilities. Building on decades of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company developed ARC Therapy. It has subsequently been awarded 10 Breakthrough Device Designations from the FDA. The Company's ARC-EX(R) System is cleared for commercial sale in the US and Europe. The Company is also developing an investigational implantable system called ARC-IM(R), designed to address several unmet needs, including blood pressure instability after spinal cord injury. It can also be paired with a brain-computer interface (BCI) and artificial intelligence (AI) to restore thought-driven movement. Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD) and its US ADRs can be traded on OTCQX (ticker: ONWRY). For more information, please visit ONWD.com. To stay informed about ONWARD's research studies, technologies, and the availability of therapies in your area, please complete this webform. For Media Inquiries: Sébastien Cros, VP Communications [email protected] Forward-Looking Statements Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors, including, but not limited to, delays in regulatory approvals, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers nor representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors, nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Trademarks: ONWARD, ARC-EX, ARC-IM, ARC-BCI, and the stylized O-Logo are proprietary and registered trademarks of ONWARD Medical. Unauthorized use is strictly prohibited. ARC-EX Indication for Use: The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, nonprogressive neurological deficits resulting from an incomplete spinal cord injury (C2-C8 inclusive). The ARC-EX System is intended to be operated in medical centers by rehabilitation professionals and at home by patients and persons providing assistance to patients, as needed. Other Investigational Products: All other ONWARD Medical devices and therapies, including ARC-IM and ARC-BCI, are investigational and not available for commercial use.

USA News Group
Sep 12th, 2026
Onward Medical lifts revenue 250% as ARC-EX sales jump fivefold.

Onward Medical lifts revenue 250% as ARC-EX sales jump fivefold. Onward Medical reported EUR4.2 million of first-half 2026 revenue, a 250% jump, and said EUR81.5 million in cash funds operations into 2028 after a EUR40 million-plus equity raise. Onward Medical NV (ONWRF) told investors on its Q2 2026 earnings call that first-half 2026 revenue reached EUR4.2 million, a 250% increase driven by a fivefold rise in ARC-EX system sales, with EUR81.5 million of cash providing a runway into 2028 after raising more than EUR40 million in fresh equity. Onward Medical NV (ONWRF) used its second-quarter 2026 earnings call to make a simple argument: the company has stopped being a clinical-stage story and started being a commercial one. Revenue for the first half of 2026 came in at EUR4.2 million, a 250% increase, and the driver was the neurostimulation developer's ARC-EX system, whose unit sales rose fivefold. Management paired that with a balance-sheet figure meant to buy patience - EUR81.5 million of cash, described as a runway into 2028, after the company raised more than EUR40 million in fresh equity. The stock responded. ONWRF last traded at 2.79, up 6.99% from the prior close of 2.61, as of the close on Friday, 11 September 2026. That move came on a broadly firm tape: the S&P 500 tracker (SPY) closed at $764.29, up 0.85%, with the Nasdaq 100 proxy (QQQ) at $714.88, up 0.87%, and the Dow tracker (DIA) at $525.79, up 0.97%. In other words, a mid-single-digit percentage gain in a micro-cap medical device name on a day when the large-cap indices moved less than a point is a company-specific reaction, not a beta trade. What the 250% revenue jump actually measures. Percentage growth is flattering when the base is small, and EUR4.2 million of half-year revenue is a small base. That is not a criticism so much as a description of where Onward sits in its life cycle. The relevant question for a device company at this stage is not the growth rate but the shape of the demand: are units moving because of one-off orders, or because a reimbursed, repeatable sales motion is taking hold? The fivefold increase in ARC-EX system sales reported on the call is the number that carries the most information. Systems placed today are the installed base that generates follow-on revenue tomorrow - consumables, service, software, and the clinical familiarity that makes the next sale to the same rehabilitation network easier. A company that grows revenue by discounting into a handful of accounts looks identical to one building a franchise for exactly one reporting period. After that, the two diverge sharply. Investors will get their first real read on which is which when the second-half numbers land. ARC-EX is Onward's external spinal cord stimulation platform, delivered non-invasively rather than through an implant. That distinction matters commercially: a non-implanted system faces a shorter adoption path through rehabilitation clinics than an implantable device, which requires surgical scheduling, hospital capital committees and a longer reimbursement fight. It is the logical first product to scale, and the company is scaling it. The runway math and what it costs shareholders. The EUR81.5 million cash position and the stated runway into 2028 are the other half of the story, and the two halves are connected. A commercial ramp is expensive. Sales headcount, clinical education, inventory and field service all consume cash ahead of the revenue they generate, which is precisely why device companies in this phase raise equity while the growth narrative is intact rather than when it is not. Onward did that, taking in more than EUR40 million. The trade is explicit: existing holders accept dilution in exchange for the company not having to negotiate from weakness in 2027. Whether that was a good trade depends on what the money buys. If the ARC-EX ramp continues and the installed base compounds, the capital was raised at a lower cost than a later round would have carried. If unit growth flattens, shareholders will have paid dilution for time and little else. The framing of a runway "into 2028" is worth reading literally. It is a statement about when cash runs out at current burn, not a claim about reaching breakeven. Nothing in the reported figures says the company expects to fund itself from operations before then. Investors in pre-profit device names should treat a stated runway as a deadline for demonstrating commercial traction, not as a solved financing problem. The details of the quarter were laid out on the company's earnings call, covered by GuruFocus. Why the ONWRF quote deserves care. ONWRF is the over-the-counter line for a company whose primary listing sits in Europe, and that has practical consequences for anyone pricing the shares. OTC lines for foreign-listed issuers typically trade thinly, with wide spreads and gaps between the American quote and the home-market price once currency is accounted for. The day's range on the ONWRF quote was 2.79 to 2.79 - a single print bracketing the whole session, which is itself a liquidity signal. That has two implications. First, a 6.99% move on a quote like this conveys less about aggregate investor opinion than the same move in a heavily traded name would. Second, execution risk is real: market orders in illiquid OTC lines can fill well away from the last print. Investors who want exposure to the underlying business generally get better pricing on the primary listing, in the home currency, if their broker allows it. What to watch through the second half. Three things will settle the debate over the next two reporting periods. * Unit cadence, not revenue percentages. Sequential ARC-EX system placements are the cleanest signal. A fivefold jump that holds its new level is a franchise; one that reverts is an order-timing artefact. * Gross margin as volume builds. Early device manufacturing is expensive per unit. Whether unit economics improve as production scales determines how much revenue Onward actually needs to reach breakeven. * Reimbursement and payer coverage. For any rehabilitation technology, the pace at which payers agree to fund treatment sets the ceiling on adoption far more than clinical enthusiasm does. * Burn against the 2028 date. If cash consumption accelerates faster than revenue, the runway shortens and another raise moves forward - and the terms of that raise would be set by whatever the unit numbers look like at the time. The bull case is straightforward and now has evidence behind it: a differentiated, non-invasive neurostimulation product is finding buyers at a rate that multiplied over a year, and the company has funded itself far enough ahead to press the advantage. The bear case is equally straightforward: EUR4.2 million of half-year revenue is a long way from covering the cost structure of a commercial medical device organisation, and every quarter that gap persists is a quarter closer to the next dilution event. The next two sets of unit numbers will decide which reading the market adopts. Key facts. * ONWRF last close: 2.79, +6.99% (as of 11 Sep 2026, 20:00 GMT) * H1 2026 revenue: EUR4.2 million, up 250% * Cash position: EUR81.5 million, runway into 2028 * Equity raised: More than EUR40 million Frequently asked questions. How much revenue did Onward Medical report for the first half of 2026? Onward Medical reported EUR4.2 million of revenue for the first half of 2026, which the company described on its second-quarter earnings call as a 250% increase. The growth was attributed primarily to a fivefold rise in sales of its ARC-EX system, the company's non-invasive spinal cord stimulation platform used in rehabilitation settings. What is ARC-EX and why does it matter to the company? ARC-EX is Onward Medical's external, non-implanted spinal cord stimulation system. Because it does not require surgery, it faces a shorter adoption path through rehabilitation clinics than an implantable device would, which typically needs surgical scheduling and hospital capital approval. It is the product driving the company's current revenue growth and its commercial ramp. How long will Onward Medical's cash last? The company said it holds EUR81.5 million in cash and described that as a runway into 2028. That figure reflects when cash would be exhausted at the current rate of spending. It is not a statement that the company expects to reach profitability by then, and further financing could be required depending on how burn tracks against revenue. How much equity did Onward Medical raise? Onward Medical raised more than EUR40 million in fresh equity, which underpins the EUR81.5 million cash position and the runway into 2028. Raising capital during a commercial ramp dilutes existing shareholders, but it allows a pre-profit device company to fund sales expansion and inventory without negotiating financing from a weaker position later. Where does ONWRF trade and what was its last price? ONWRF is the over-the-counter quote for the shares. It last traded at 2.79, up 6.99% from a prior close of 2.61, as of the close on Friday, 11 September 2026. The day's range was 2.79 to 2.79, a sign of thin trading typical of OTC lines for companies whose primary listing is elsewhere. What should investors watch next from Onward Medical? The clearest signals are sequential ARC-EX unit placements rather than headline revenue percentages, gross margin progression as manufacturing volume builds, payer reimbursement coverage for the therapy, and cash burn measured against the stated 2028 runway. If burn outpaces revenue growth, the timing of any additional equity raise moves forward.

Euronext
Sep 11th, 2026
ONWARD lists on Euronext Brussels and Euronext Amsterdam

€86.5 million raised – market capitalisation of €391 million Dual-listing aims to increase exposure to new investors 162nd listing on

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