Chronic Pain

The veil is starting to lift on medical robotics startup Mendaera as it exits stealth mode and heads toward regulatory submission with a design freeze on its first system and verification and validation imminent. San Mateo, California–based Mendaera was founded by two former Auris Health leaders and has financial support from Dr. Fred Moll, the Auris and Intuitive Surgical co-founder who is known as the father of robotic surgery. “Among the innovators in the field, Mendaera’s efforts to make robotics commonplace earlier in the healthcare continuum are unique and can potentially change the future of care delivery,” Moll said in a news release announcing his investment in the startup. But Mendaera isn’t a surgical robotics developer. Instead, they’re working on technology that combines robotics, artificial intelligence and real-time imaging in a compact device “no bigger than your fist” for procedures including percutanous instruments. That’s according to Mendaera co-founder and CEO Josh DeFonzo, who offered new details about his startup’s technology and goals in an exclusive interview as he announced the acquisition of operating room telepresence technology developed by Avail Medsystems. “We’re a very different form factor of robot that focuses on what I’ll describe as gateway procedures,” DeFonzo said. “… It’s a different category of robots that we don’t believe the market has seen before [as] we’re designing and developing it.” Those procedures include vascular access for delivery of devices or therapeutic agents, access to organs for surgical or diagnostics purposes, and pain management procedures such as regional anesthesia, neuraxial blocks and chronic pain management. DeFonzo declined to go into too much detail about specific procedures because the product is still in the development stage. “The procedures that we are going after are those procedures that involve essentially a needle or a needle-like device and real-time imaging, and as such, there are specific procedures that we think the technology will perform very well at,” DeFonzo said. “However, the technology is also designed to be able to address any suite of procedures that use those two common denominators: real-time imaging and a percutaneous instrument. And the reason that’s an important point to make is that oftentimes, when you are a specialist who performs these procedures, you don’t perform just one. You perform a number of procedures: central venous catheters (CVCs), peripherally inserted central catheter (PICC) lines, regional anesthetic blocks that are in the interscalene area or axial blocks. The technology is really designed to enable specialists — of whom there are many — the ability to perform these procedures more consistently with a dramatically lower learning curve.” Preclinical testing has shown the technology has improved accuracy and efficiency compared to freehand techniques, regardless of the individual’s skill level, DeFonzo said User research spanned around 1,000 different healthcare providers ranging from emergency medicine, interventional radiology, licensed medical doctors, nurse practitioners and physician’s assistants. “It seems to be very stable across user types,” DeFonzo said. “So whether somebody is a novice, of intermediate skill level or advanced, the robot is a great leveler in terms of being able to provide consistent outcomes. Whereas when you look at the same techniques performed freehand, the data generally tracks with what you would expect: lesser skilled people are less accurate, more experienced people are more accurate. But even in that most skilled category, we do find that the robot makes a fairly remarkable improvement on accuracy and timeliness of intervention.” Last year, the startup expanded into a production facility to accommodate growth and volume manufacturing for the product’s launch, and said its system will be powered by handheld ultrasound developer Butterfly Network’s Ultrasound-on-Chip technology. Mendaera’s aim is to eventually deploy these systems “to the absolute edge of healthcare,” DeFonzo said, starting with hospitals, ambulatory surgical centers and other procedural settings, and then pushing to alternative care sites and primary care clinics as evidence builds to support the technology. “The entire mission for the company is to ensure essentially that high-quality intervention is afforded to every patient at every care center at every encounter,” he said. “We want to be able to push that as far to the edge of healthcare as possible, and that’s certainly something we aim to do over time, but it’s not our starting point explicitly. … As a practical starting point, however, we do see ourselves working in the operating room, in the interventional radiology suite, and likely in cath labs to facilitate these gateway procedures, the access that is afforded adjacent to a larger intervention.” Mendaera anticipates submitting its system to the FDA for review through the 510(k) pathway by the end of 2024 with the goal of offering the product clinically in 2025. “What we really want to do with this technology is make sure that we’re leveraging not just technological trends, but really important forces in the space — robotics, imaging and AI — to dramatically improve access to care,” DeFonzo said. “… Whether you’re talking about something as basic as a vascular access procedure or something as complex as transplant surgery or neurosurgery, we need to leverage technology to improve patient experience, we need to leverage technology to help hospitals become more financially sustainable, ultimately improving the healthcare system as we do it. So our vision was to utilize technology to provide solutions that aggregate across many millions if not tens and hundreds of millions of procedures to make a ubiquitous technology that really helps benefit our healthcare system.” The company R&D group will work with employees from Avail on how to best add the telepresence technology to the mix. “We see a lot of power in what the Avail team has built,” DeFonzo said. “Bringing that alongside robotic technology, our imaging partnerships and AI, we think that we’ve got a really good opportunity to digitize to a further extent not only expertise in the form of the robot, but clinical judgment, like how do you ensure that the right clinician and his or her input is present ahead of technologies like artificial intelligence that hopefully augment all users in an even more scalable way.”

The Danish biopharmaceutical company, Tetra Pharm Technologies, is proud to announce the launch of its pain-relieving prescription drug, XATEPA®, in the United Kingdom. COPENHAGEN, Denmark, March 19, 2024 /PRNewswire/ -- Following last year's successful launch of XATEPA® in Germany, the cannabinoid-based product will now become available to patients in the United Kingdom during Q2 2024. XATEPA® is a carefully formulated drug designed to provide effective relief from chronic pain as well as discomfort arising from MS spasms and nausea. The innovative sublingual spray is devised as an enabling technology to provide optimal conditions for cannabinoid uptake and efficacy. Continue Reading Pharmacy Entrance "We are thrilled to launch XATEPA® in the United Kingdom. We believe the product has the potential to make a significant impact on the lives of many patients. Our strategy is to continuously invest in building our pipeline of new drug candidates targeting the endocannabinoid system and related disease indications. The launch of XATEPA® across multiple markets allow us to scale-up long-term research and development efforts, which will always be our primary focus", says Martin Rose, Chief Executive Officer, Tetra Pharm Technologies. For the distribution of XATEPA® in the United Kingdom, Tetra Pharm Technologies has entered a strategic agreement with 4C LABS Ltd. who cooperate with a wide network of clinics, doctors, and patient organizations. The agreement ensures that patients in the United Kingdom and Channel Islands can get access to XATEPA® as all doctors, physicians and clinics can prescribe the product to their patients. "4C LABS are excited to be the exclusive distributors in the United Kingdom for the suite of Tetra Pharm Technologies' cannabinoid-based prescription drugs. Doctors and patients across the United Kingdom have been asking for drugs that offer an easy and consistent delivery method. This is exactly what XATEPA®'s novelty formulation and measured dose per spray offers", says James Smith, Chief Revenue Officer, 4C LABS Ltd. Tetra Pharm Technologies is planning to introduce XATEPA® in several additional European and overseas markets in 2024. About Tetra Pharm Technologies ApS Tetra Pharm Technologies is a Danish biopharmaceutical company established in 2018 with a vision to be a leader in research and development of pharmaceutical drugs for the treatment of diseases related to the endocannabinoid system. For more information, please visit For further information Jacob Schlundt [email protected] +45 5197 6225 Photo - Logo - SOURCE Tetra Pharm Technologies

NRx Pharmaceuticals Board of Directors has authorized its Chairman, CEO, and management to take all necessary steps to affect the Dividend and Royalty Rights to NRXP Shareholders and applicable warrant holders Dividend is intended to distribute 49% of HOPE Therapeutics stock and a Royalty Right for 1% of Ketamine sales made by HOPE Effective date to be declared as soon as all required legal, accounting, and regulatory steps have been completed Proxy voting instructions included below RADNOR, Pa., March 18, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company") today Announced that its Board of Directors (Board) has authorized its Chairman and management to take all necessary steps to affect a Dividend of HOPE Therapeutics ("HOPE") stock along with a royalty right of 1% of Ketamine sales to NRXP Shareholders and applicable warrant holders. The intent of the Board is to distribute 49% of HOPE stock in this dividend. Shares of HOPE are planned to be publicly listed "This Dividend is another important step to building value for all of the Company's stakeholders. We are pleased to be taking these concrete steps to unlocking the power and value of our Ketamine franchise for the investors who have supported the company and patients who need this potentially lifesaving product," said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals and co-CEO of Hope Therapeutics. "As we build HOPE into a thriving, publicly-traded Specialty Pharmaceutical company we look forward to continuing to reward our investors." Instructions and further details will be communicated through the Company's website and usual channels as they become available. HOPE Therapeutics was recently formed to advance HTX-100 (IV Ketamine) to a New Drug Application filing and subsequent commercialization in the near term, and also facilitate sales of ketamine through high quality 503 a and 503b licensed pharmacies beginning in 2Q24. HOPE will additionally focus on digital therapeutics and other technologies to extend the pharmacologic effect of ketamine. Together, these efforts are intended to create a revenue generating Specialty Pharmaceutical company in 2024. Proxy Voting By now shareholders should have received a proxy statement and voting card for NRx's special meeting to be held on March 21, 2024. All votes need to be completed by March 20, 2024. If you have a control number, you can vote here: If you have not yet received any voting instructions, the Company can help. If you have any issues with voting, please reach out to Stephen Freyman of Alliance Advisors for immediate assistance. Stephen's contact info is sfreyman@allianceadvisors.com T: 1 (973) 518 3365. About NRx Pharmaceuticals NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI. NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality. About HOPE Therapeutics, Inc. HOPE Therapeutics, Inc. ( ) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. Notice Regarding Forward-Looking Statements The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at . Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise. For further information: CORPORATE CONTACTS: Jeremy Feffer, LifeSci Advisors, Inc. jfeffer@lifesciadvisors.com Matthew Duffy, Chief Business Officer mduffy@nrxpharma.com Company Codes: NASDAQ-NMS:NRXP