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On Thursday, May 4th, our clinical team visited the Orthopedic Hospital Sonnenhof in Bern, Switzerland, for the second and final Site Initiation Visit of SentryX’s first-in-human clinical trial. During the day, we collaborated closely with their team to prepare for the Phase Ib study. As a result, both hospitals are now ready to include their first patients. We thank our clinical partners in Bern for their dedication and professionalism and are very happy to start this exciting journey together.

May 2023 - Both sites initiated for the upcoming Phase 1 clinical trial

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On Thursday April 13th, another milestone was reached in our longstanding goal to improve the lives of patients undergoing musculoskeletal surgery. On this day members from the SentryX team, together with members from the Department of Orthopedics from the Elisabeth Hospital in Tilburg, conducted the Site Initiation Visit (SIV) for the upcoming Phase 1 clinical trial. During a SIV a hospital (site) is prepared and set up to perform the clinical study. After a day of hard work everyone involved was brought to the level were we can now look forward with confidence to include our first patient. This important day was concluded in good spirits with a dinner for the whole team. On Thursday May 4th we will perform the second SIV in hospital Sonnenhof in Bern, Switserland. We very much look forward to this moment as with both sites initiated our Phase 1 trial is really about to begin!

On Thursday April 13th, SentryX conducted the Site Initiation Visit (SIV) for the upcoming Phase 1 clinical trial at the Department of Orthopedics from the Elisabeth Hospital in Tilburg.

May 2023 - First site initiated for the upcoming Phase 1 clinical trial

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On Wednesday April 19th, Jasper Steverink successfully defended his academic dissertation ‘Postoperative Skeletal Pain; Development of Non-Opioid Treatment Strategies’ in the Academiegebouw in Utrecht. During an official oral test, five professors from the Utrecht University were given the opportunity to challenge the PhD candidate on his scientific work. A lively discussion followed whereby many aspects of skeletal pain after surgery and the development of our unique hydrogel as promising non-opioid treatment solution were debated. Jasper, supported by his colleagues Hein Jonkman and Floris van Tol, did an outstanding job of replying to all questions during the examination. Following tradition, at exactly 45 minutes into the discussion, the Beadle interrupted with ‘Hora Est’ prompting the group of professors to withdraw and deliberate on the quality of the defense. Just ten minutes later and after unanimous agreement, Jasper was awarded the title PhD from professor Jos Malda, who together with Jorrit-Jan Verlaan and Susanna Piluso coached him during this scientific work. We congratulate Jasper Steverink MD, PhD with this great achievement!

On Wednesday April 19th, Jasper Steverink successfully defended his academic dissertation ‘Postoperative Skeletal Pain; Development of Non-Opioid Treatment Strategies’ in the Academiegebouw in Utrecht.

May 2023 - Jasper Steverink successfully defended PhD dissertation

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SentryX is thrilled to have been awarded €15.5 million in funding from the EIC Accelerator program, advancing its mission to drastically improve recovery after musculoskeletal surgery and make healthcare more affordable.
The funds will be used to accelerate the clinical development of BR-003: an innovative long-acting co-implantable anesthetic that will be applied in spinal fusion surgery before expanding to other musculoskeletal procedures. Stay tuned for updates on the first clinical trial, which will commence soon.
Many thanks to the EIC and everyone who helped on the proposal, especially team IRIS with the RvO who provided invaluable guidance and support throughout. Also, congratulations to the <a href="https://siliconcanals.com/news/startups/eic-selects-32-european-startups/">six (!) other </a><a href="https://siliconcanals.com/news/startups/eic-selects-32-european-startups/" target="_blank" rel="noreferrer noopener">Dutch startups</a> who were successful in this round.

SentryX is thrilled to have been awarded €15.5 million in funding from the EIC Accelerator program, advancing its mission to drastically improve recovery after musculoskeletal surgery and make healthcare more affordable.

April 2023 - SentryX Awarded €15.5M in EIC Accelerator Funding

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SentryX has achieved an important milestone in the global protection of its technology, as the United States Patent and Trademark Office (USPTO) has formally awarded the patent for its innovative concept of co-implanting local anesthetics alongside surgical screws.

In total SentryX has submitted 6 patent families to safeguard its concepts and the foundational hydrogel technology. SentryX is excited about this achievement and eagerly anticipates bringing this technology to the market in the upcoming years.

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The United States Patent and Trademark Office (USPTO) has formally awarded the patent for its innovative concept of co-implanting local anesthetics alongside surgical screws.

March 2023 - First patent officially granted in the United States

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SentryX welcomes Lin Roest as the newest member of its clinical operations team. With over 14 years of experience in clinical research, Lin will be of great value as the company completes the observational study, carries out a Phase Ib clinical trial, and prepares for the subsequent confirmatory trial.

After obtaining a master’s degree in Animal Science, Lin worked at Cardialysis, Novo Nordisk, and Julius Clinical before becoming a Clinical Trial Manager at ProQR Therapeutics. Lin started her work at SentryX in February 2023, and we are very happy to have her on board.

SentryX welcomes Lin Roest as the newest member of its clinical operations team.

February 2023 - SentryX Strengthens Clinical Operations Team

SentryX is happy to announce the formal approval of its first clinical trial. The Phase Ib study will investigate an innovative local pain treatment specifically designed for spine fixation surgery. The trial is centered around safety in humans and may also provide an early indication of efficacy. After promising preclinical results, this approval marks SentryX’s entrance into the clinical stage. The study will commence in the second quarter of 2023, in the Netherlands and Switzerland, and the first results are expected six months later.
Background
There is a troubling lack of safe and effective pain treatments after major surgery. Every year, more than 25 million people undergo musculoskeletal procedures to maintain mobility and quality of life. As the population ages, this number is only expected to grow. To keep musculoskeletal surgery accessible and affordable, there is an increasing focus on innovative surgical techniques enabling enhanced recovery after surgery. However, the intense pain that patients experience in the first few days after surgery remains a major bottleneck, especially since opioids are still the dominant pain treatment. Opioids provide insufficient pain relief in up to 80% of patients and routinely cause side-effects such as nausea, obstipation, or dizziness. Severe side-effects occur in 13,6% of patients, resulting in longer hospital stays, higher costs, and increased readmission rates. Even today, patients generally remain in the hospital for several days, mostly because of pain and opioid-related side-effects. For this problem, SentryX believes it can realize a radical change. Through sustained, non-opioid pain relief after major surgery, its goal is to enhance recovery, improve outcomes, free up scarce hospital capacity, and save costs.
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SentryX was founded late 2017 to realize improved pain control after major surgery. One of its founders, a spine surgeon from the University Medical Center Utrecht, has long witnessed the downsides of existing pain treatments like so many of his colleagues. Rather than administering opioids, which act on the central nervous system, he began looking for a way to block pain locally. Local anesthetics are widely used in dentistry, as epidural anesthesia, and in many other indications. They are well-known for their comparative safety, efficacy, and consistency when compared to opioids. In major surgery, however, local anesthetics are scarcely used because they work for only 6-8 hours and can be difficult to inject consistently near the relevant nerves and pain receptors. Together with the UMC Utrecht, SentryX has found a way to circumvent these limitations using revolutionary local drug delivery technology. Their first solution is specifically designed for spine fixation surgery and could clear the way for many other applications to follow.

SentryX is happy to announce the formal approval of its first clinical trial. The Phase Ib study will investigate an innovative local pain treatment specifically designed for spine fixation surgery.

January 2023 - Green Light for SentryX's First Clinical Trial

SentryX is pleased to announce that in November, a Clinical Trial Application (CTA) has been submitted to Swissmedic, the Swiss surveillance authority for medicines and medical devices, and ethics committee for a first-in-human Phase 1b clinical trial for its lead candidate, BR-003. The trial will take place at the Orthopädie Sonnenhof Clinic in Bern and two hospitals in the Netherlands, and will enroll patients undergoing elective lumbar spine surgery with pedicle screw instrumentation.
The CTA submission builds on several years of research and development resulting in strong preclinical safety data as well as compelling in-vivo evidence of the local performance of the candidate product. SentryX is well-prepared and excited to be entering the clinical development phase.

SentryX is pleased to announce that a Clinical Trial Application (CTA) has been submitted to Swissmedic and ethics committee.

December 2022 - First Clinical Trial Application Submitted

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The field of spine surgery is rapidly evolving, continuously optimizing the perioperative process to improve outcomes after surgery. The philosophy of optimization is embodied by the Enhanced Recovery After Surgery (ERAS) society. An exciting new development is the implementation of robotic assistance during pedicle screw implantation for spinal fusion.
Although still in its early phases, robotic surgery aims to enhance recovery after surgery through improving the accuracy and efficiency of screw placement, thus reducing tissue damage. The aim of robotic surgery matches the vision of SentryX: by improving accuracy of pain treatment, adverse effects of treatment are minimized. The combination of robotic surgery and SentryX innovative pain treatment could lead to major enhancement of recovery after surgery. Together with our advisors, SentryX provides a sneak peek of what the future could look like in <a href="https://cms.sentryx.nl/uploads/Whitepaper-Robotic-Spine-Systems.pdf" target="_blank" rel="noreferrer noopener">our latest whitepaper.</a>

SentryX whitepaper on the rapidly evolving field of spine surgery and how postoperative pain treatment can play a pivotal role

December 2022 - Future Outlook Robotic Surgery and BR-003

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SentryX is proud to welcome Alex Vaccaro, MD, PhD, MBA, to its Advisory Board. Internationally regarded as a leading expert in spine surgery, dr. Vaccaro will be able to provide invaluable guidance and support during the clinical development and implementation of BR-003. Dr. Vaccaro is current president of the Rothman Orthopaedic Institute in Phildelphia and has also served in many leading roles in the AO Spine community. He has officially taken up his position as SentryX’s strategic advisor on October 1st, 2022.

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SentryX is proud to welcome Alex Vaccaro, MD, PhD, MBA, to its Advisory Board.

October 2022 - Alex Vaccaro Joins SentryX Advisory Board

SentryX has started a collaboration with the Medical Innovation and Technology Department of the Radboud University Medical Center, one of leading centers in the field of early HTA-modeling. 
Together an HTA-model will be developed that connects the medical performance of BR-003 to the expected benefits for the patient, hospital, and society. Clinical trial results and post-marketing surveillance data will help validate and improve the model, which may also be applied to novel medical technologies under development.

SentryX has started a collaboration with the Medical Innovation and Technology Department of the Radboud University Medical Center

September 2022 - HTA-Modeling Collaboration Started

SentryX received a Notice of Allowance from the United States Patent and Trademark Office for its first patent application. Previously, the patent also received an Intention to Grant status from the European Patent Office. These two milestones represent highly important steps towards the global protection of both SentryX’s surgical applications and their underlying hydrogel technology. Presently, SentryX has submitted six patent applications.

SentryX received a Notice of Allowance from the United States Patent and Trademark Office for its first patent application.

September 2022 - Notice of Allowance for First Patent

The development of SentryX’s hydrogel technology, and its application in providing sustained release of local pain killers after surgery has been published in Acta Biomaterialia, a leading peer-reviewed biomaterials journal.

The publication elaborates on the in vitro raw material development and hydrogel synthesis, and provides ex vivo clues on its feasibility in spine surgery. The involvement of multiple scientific advisors makes the work a true joint effort. The publication represents the first step towards clinical translation of developments in the lab and is followed by in vivo safety testing of the hydrogel technology. The results have previously been presented at the Global Spine Congress in Paris 2021, receiving the attention of a global audience of spine surgeons. Find the publication <a href="https://www.sciencedirect.com/science/article/pii/S1742706122002768" target="_blank" rel="noreferrer noopener">here</a>.

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The development of SentryX’s hydrogel technology, and its application in providing sustained release of local pain killers after surgery has been published in Acta Biomaterialia

July 2022 - Publication of Hydrogel Technology

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The University Medical Center Utrecht has received a €600.000 research grant from the Dutch Cancer Society (KWF) for its ‘CODED’ project (Controlled Release of Drugs in Glioblastoma). The project employs SentryX’s proprietary hydrogel technology to develop a hemostatic adhesive drug carrier that allows for localized, controlled release of therapeutics directly to brain tissue following local tumor resection. This revolutionary approach can prevent severe bleeding after brain surgery and circumvents the blood-brain-barrier to enable increased local drug concentrations with fewer side-effects in the rest of the body. The project is headed by dr. Raymond Schiffelers, full professor in Nanomedicine, and involves contributions from dr. Elly Hol, full professor in Glia Biology of Brain Diseases, and dr. Pierre Robe, full professor in Neurosurgery. The project has commenced in the second half of 2022 and will last for approximately three years. More information (in Dutch) can be found <a href="https://www.kwf.nl/onderzoek/onderzoeksdatabase/coded-gecontroleerde-afgifte-van-geneesmiddelen-bij-de-hersentumor" target="_blank" rel="noreferrer noopener">here</a>.

The University Medical Center Utrecht has received a €600.000 research grant from the Dutch Cancer Society (KWF) for its ‘CODED’ project (Controlled Release of Drugs in Glioblastoma)

April 2022 - Partner in KWF Research Grant

SentryX, a spin-off of the University Medical Center Utrecht (the Netherlands) today announced that it raised €3.2M in seed funding for the development of their next-generation pain relief therapeutic platform. The round includes an investment from the Utrecht Health Seed Fund.
Every year, millions of people in Europe and the US undergo a significant orthopedic surgical procedure and experience intense post-operative pain as a result. Despite the application of systemic pain medication, most patients still report insufficient pain relief, hampering post-operative recovery. SentryX’s innovative pain relief therapy platform focuses on minimizing post-operative pain to improve the overall patient experience and quality of care.

SentryX, a spin-off of the University Medical Center Utrecht (the Netherlands) today announced that it raised €3.2M in seed funding for the development of their next-generation pain relief therapeutic platform.

April 2021 - SentryX closes €3.2M seed funding round for the development of next generation pain relief therapeutics

FDA Takes New Steps to Stimulate Development of Non-Opioids in Acute Pain Management
The United States Food and Drug Administration (FDA) has taken new steps aimed at fostering the development of non-addictive alternatives to opioids in acute pain management. The FDA targets pharmaceuticals against pain lasting up to 30 days, typically in response to some form of tissue injury such as trauma or surgery. Decreasing opioid exposure and preventing addiction are seen as core components of combating the opioid epidemic.
In a draft guidance, the FDA provides clear recommendations for companies developing non-opioid analgesics for acute pain. Three key aspects are highlighted:
Which types of drug development programs may be appropriate to generate the data needed to support an indication for acute pain management
The use of claims surrounding the elimination or reduction of opioids in drug labeling and the data needed to support those claims
Potential use of the FDA’s expedited programs to support the development program
The US government has prioritized beating the opioid epidemic and has taken express steps towards developing non-addictive alternatives to opioids in acute pain management. The full draft guidance can be found <a href="https://www.fda.gov/news-events/press-announcements/fda-takes-steps-aimed-fostering-development-non-addictive-alternatives-opioids-acute-pain-management">here.</a>

FDA Takes New Steps to Stimulate Development of Non-Opioids in Acute Pain Management

February 2022 - FDA Takes New Steps to Stimulate Development of Non-Opioids in Acute Pain Management

News

SentryX Awarded €15.5M in EIC Accelerator Funding