Introduction: Cochlear implantation has become the standard of care for the treatment of moderate-to-profound bilateral sensorineural hearing loss. However, current technologies, all of which rely on an external sound processor, have intrinsic limitations that prevent certain activities and diagnostics, thus hampering full integration into a patient's lifestyle. The Envoy Medical (White Bear Lake, MN, USA) Acclaim^® fully implanted cochlear implant is a new device currently undergoing testing that has been designed to alleviate many of the current constraints by housing all components within the patient, thus allowing for near-constant use in many environments that are not conducive to a traditional cochlear implant. Methods: As part of an Early Feasibility Study, three adult implant candidates were implanted with the Acclaim^® cochlear implant. Surgical video and photography were taken, and initial observations were recorded. Implantation with the Acclaim^® device is largely similar to a traditional cochlear implant, with modifications to allow room for the implanted sensor as well as the implantation of a battery in the subcutaneous tissues of the chest. Results: This study demonstrates a step-by-step overview of implanting the Acclaim^® and discusses initial insight and experiences with the first three implantations with this new device. Conclusions: All three surgeries proceeded without complication, and at activation, all three patients were hearing through their devices. Surgery is more technically challenging compared to a standard cochlear implant, but the skills needed can all be mastered by a dedicated otologic surgeon.

26 Aug 2023·Cureus

A Systematic Review on the Effect of Strontium-Doped Nanohydroxyapatite in Remineralizing Early Caries Lesion

Review

Author: Ashik P, Mohammed ; M, Ameena ; Rajendran, Ratheesh ; Hameed, Hana ; Paul, Princy ; Antony, Delphine P

The aim of this study is to review the potential of strontium-doped nanohydroxyapatite (SrnHAP) as a biomaterial for remineralizing early carious lesions. Publications from 2012 to 2022 were included based on the patient/population, intervention, comparison, and outcomes (PICO) framework, focusing on demineralized enamel treated with strontium-doped nanohydroxyapatite compared to other remineralizing agents, with the primary outcome being remineralization capacity. Electronic databases, namely, PubMed, Cochrane Library, and Google Scholar, were explored from March 31, 2023, to April 10, 2023. Only English language studies were included, while certain research types and studies on bovine teeth were excluded. Bias was assessed using the Cochrane methodology. Five studies were synthesized, all using extracted human maxillary premolars. Four studies focused on remineralizing enamel, while one study focused on remineralizing dentin. Among these studies, comparisons were made between different strontium concentrations and various remineralizing agents such as nanohydroxyapatite (nHAP), Acclaim, casein phosphopeptide-amorphous calcium phosphate (CPP-ACP), and NovaMin. X-ray diffraction analysis was used to examine hydroxyapatite formation, while scanning electron microscopy (SEM) and transmission electron microscopy (TEM) were used for characterization. Additionally, one study evaluated the mechanical properties of partially demineralized dentin specimens. This study was registered in the PROSPERO under the ID CRD42023397413 and completed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

13 Apr 2022·International Journal of Clinical Pediatric Dentistry

Comparison of Remineralization Potential of Casein Phosphopeptide: Amorphous Calcium Phosphate, Nano-hydroxyapatite and Calcium Sucrose Phosphate on Artificial Enamel Lesions: An In Vitro Study

Article

Author: Reddy, Divya ; Azher, Umme ; Sebastian, Ronin ; Paul, Santhosh T

Aim and objectiveTo evaluate and compare the remineralization potential of CPP-ACP, nano-hydroxyapatite, and calcium sucrose phosphate toothpaste on artificial enamel caries lesions by means of microhardness testing.Materials and methodsTwenty sound human primary molars, extracted for therapeutic reasons were selected for this study. From each tooth, two enamel specimens were prepared and embedded in acrylic resin blocks, and each block contains five tooth samples. After polishing, the baseline hardness of the enamel surface (KHN) was determined by Knoop microhardness testing. Then the specimens were randomly assigned into four groups (n = 10), according to the remineralizing agent used: group I: Control, group II: GC Tooth Mousse^TM (CCP-ACP), group III: Acclaim^TM (nano-HAP), and group IV: EnaFix (CaSP). The specimens were then immersed in a demineralizing solution and post-lesion KHN values were obtained as baseline measurements. Later remineralizing agent was applied and after 7 days of remineralization, posttreatment KHN tests were conducted.ResultsData were analyzed using paired t- test, analysis of variance, and Tukey HSD test. Mean enamel surface microhardness (KHN) values after remineralization shows that group IV (EnaFix^TM) had maximum hardness number (114.71 ± 12.27) followed by group III (Acclaim) (85.14 ± 22.82) and group II (GC Tooth Mousse) (56.42 ± 19.90). The difference was statistically significant (p < 0.001). Similarly the %SMHR was also highest in group IV (EnaFix), followed by group III (Acclaim) and group II (GC Tooth Mousse).ConclusionEnaFix (calcium sucrose phosphate) shows a maximum increase in the enamel surface microhardness followed by Acclaim (nano-HAP) and GC Tooth Mousse.Clinical significanceCalcium Sucrose Phosphate in toothpaste strengthened the enamel more than nano hydroxyapatite and CPP-ACP, and can be an alternative to the use of fluoride toothpaste in children.How to cite this articleSebastian R, Paul ST, Azher U, et al. Comparison of Remineralization Potential of Casein Phosphopeptide: Amorphous Calcium Phosphate Nano-hydroxyapatite and Calcium Sucrose Phosphate on Artificial Enamel Lesions: An In Vitro Study. Int J Clin Pediatr Dent 2022;15(1):69-73.

News (Medical) associated with Isosorbide Mononitrate/L-Arginine

12 Mar 2024

·www.prnewswire.com

Genprex Receives Notice of Patent Grant for Korean Patent Claiming Reqorsa® Immunogene Therapy with PD-1 and PD-L1 Antibodies to Treat Cancers

Expands on the previously granted patents covering the use of REQORSA in combination with immune checkpoint inhibitors applicable to Genprex's Acclaim-2 and Acclaim-3 clinical trials AUSTIN, Texas, March 12, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the Korean Patent Office has issued a Notice of Patent Grant for a broad patent that covers the use of Genprex's lead drug candidate, Reqorsa® Immunogene Therapy, in combination with anti-PD-1 and PD-L1 antibodies through 2037. This patent will expand on the previously granted patents in the U.S., Japan, Mexico, Russia, Australia, Chile and China to cover the use of REQORSA in combination with immune checkpoint inhibitors, e.g., PD-1 and PD-L1 inhibitors. These patents are applicable to Genprex's Acclaim-2 and Acclaim-3 clinical trials. "We continue to secure exclusivity for our drug combinations of REQORSA with PD-1 antibodies, such as Keytruda® and PD-L1 antibodies, such as Tecentriq®, for the treatment of cancer in some of the largest markets," said Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex. "It is important that we continue to add to our global intellectual property estate and to build protection around our drug combinations as we advance REQORSA through the clinic." The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions - a Phase 1 dose escalation portion, a Phase 2a expansion portion, and a Phase 2b randomized portion. The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.'s Keytruda® in patients with late-stage non-small cell lung cancer (NSCLC) whose disease has progressed after treatment with Keytruda. Patients are treated at the 0.06 mg/kg dose level in the first cohort of patients and, subject to the Acclaim-2 SRC approval, will be treated at successive dose levels of 0.09 mg/kg and 0.12 mg/kg. Genprex expects to complete enrollment in the Phase 1 dose escalation portion of the Acclaim-2 study in the second half of 2024. Genprex was granted FDA Fast Track Designation for the Acclaim-2 patient population. The Acclaim-3 study has two portions - a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022 Genprex filed with the FDA the protocol for the Phase 1/2 Acclaim-3 clinical trial using a combination of REQORSA and Genentech's Tecentriq® as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The Phase 1 portion of the Acclaim-3 study is open for enrollment, and Genprex expects to complete the Phase 1 portion of the study by the second half of 2024. Genprex was granted FDA Fast Track Designation and Orphan Drug Designation for the Acclaim-3 patient population. About Genprex, Inc. Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells. Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website, registering for Email Alerts and by following Genprex on Twitter, Facebook and LinkedIn. Cautionary Language Concerning Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A – Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended December 31, 2022. Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications; the timing and success of Genprex's clinical trials and regulatory approvals; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex's future growth and financial status, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex's commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex's intellectual property and licenses. These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law. Genprex, Inc. (877) 774-GNPX (4679) GNPX Investor Relations [email protected] GNPX Media Contact Kalyn Dabbs [email protected] SOURCE Genprex, Inc.

Orphan DrugImmunotherapyFast TrackPhase 1Gene Therapy

22 Jan 2024

·www.prnewswire.com

MCRA Provides Anzu Special Acquisition Corp I with Strategic Diligence Support Leading to Envoy Medical Merger (NASDAQ: COCH)

WASHINGTON , Jan. 22, 2024 /PRNewswire/ -- MCRA, LLC, a leading medical device and biologics focused clinical research organization (CRO) and advisory firm integrating seven core services [U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH)] is pleased to announce its role in providing strategic due diligence support for Anzu Special Acquisition Corp I, ahead of the recent deal with Envoy Medical ("Envoy" or "Envoy Medical") (NASDAQ: COCH). Continue Reading Anzu Special Acquisition Corp I recently completed a business combination with Envoy Medical, developer of the Acclaim®, an investigational fully implanted cochlear device that received FDA's Breakthrough Device Designation in 2019, and the Esteem®, an FDA-approved fully implanted active middle ear implant. MCRA's clinical, regulatory, reimbursement, and quality assurance experts were retained by Anzu Special Acquisition Corp I to provide due diligence support ahead of the transaction with Envoy Medical Corporation. The MCRA team reviewed both of Envoy Medical's fully implanted hearing devices and assessed the overall strategy and risk profile. By compiling findings on critical areas, MCRA provided Anzu Special Acquisition Corp I with pertinent analysis to close the deal with Envoy Medical, allowing them to complete the business combination, resulting in Envoy becoming a publicly listed company (NASDAQ: COCH). MCRA provided strategic due diligence support for Anzu Special Acquisition Corp I ahead of the deal with Envoy Medical. Post this MCRA's due diligence service line equips potential investors with the information they need to make informed decisions, mitigate risks, and maximize the chances of a successful investment in the dynamic and highly regulated medical device and biologics industry. Todd Courtney, Vice President, Anesthesia, Respiratory, Sleep, & ENT Regulatory Affairs at MCRA states, "My team was excited to work with Anzu Special Acquisition Corp I on such an important deal. By reviewing Envoy Medical's devices and regulatory history with FDA, we were able to aid the company in its investment strategy to bring first-of-a-kind fully implantable hearing devices to the market that have the potential to significantly increase quality-of-life for patients needing these devices." John McDermott, Vice President, Reimbursement Strategy and Policy at MCRA states, "By reviewing current payer policies on hearing devices, we guided Anzu Partners on the viability of establishing reimbursement at the price point they needed to ensure that Envoy Medical's technology will be available for patients, both now and in the future. We are proud to have assisted on such an important due diligence project." Whitney Haring-Smith, former CEO of Anzu Special Acquisition Corp I states, "MCRA was a dedicated and diligent partner in our evaluation of Envoy Medical, and we are grateful for their perspective on the pathways to FDA approval and Medicaid/Medicare reimbursement." "Once the merger process was completed, I was able to see some of the diligence work that MCRA had done for Anzu and was impressed by its ability to distill complicated topics into useable pieces of information," commented Brent Lucas, CEO at Envoy Medical. Anthony Viscogliosi, CEO of MCRA states, "as a long-term entrepreneur and investor in the medical device industry, I have seen firsthand the value the MCRA team provides by conducting comprehensive diligence in the areas of clinical, regulatory, reimbursement, quality and compliance for these important transactions. I am pleased to see the successful business combination of Anzu Special Acquisition Corp I and Envoy Medical as a result of the diligence work performed." About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its client's industry experience, integrating its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA's integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, the United Kingdom, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, respiratory, ENT, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices. About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specialized in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. About Envoy Medical: Envoy Medical, Inc. (NASDAQ: COCH), headquartered in White Bear Lake, Minnesota, is a hearing health company focused on providing innovative medical technologies. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to provide patients with improved access, usability, independence and quality of life. For more information, please contact: Alyssa Howard, Vice President, Business Development Phone: 215.870.3952 | Email: [email protected] SOURCE MCRA, LLC

Acquisition

02 Oct 2023

·www.biospace.com

Breakthrough Hearing Health Technology Firm, Envoy Medical Begins Trading On NASDAQ

Envoy Medical to Begin Trading October 2nd on NASDAQ with Ticker COCH Management to Attend Major Medical Conference White Bear Lake, Minnesota--(News - October 2, 2023) - Envoy Medical® Inc (NASDAQ: COCH) ("Envoy Medical"), a hearing health company, today announced that its common stock is now trading on the NASDAQ under the symbol COCH. Envoy Medical is a medical technology company focused on fully implanted hearing devices. Envoy Medical's primary device is the fully implanted Acclaim® cochlear implant, which is distinct from the partially-implanted, partially-external devices currently available. Acclaim® was granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) and is currently in clinical trials. Envoy Medical intends to target a significantly under-penetrated cochlear implant market, which it believes to be more than $80 billion in the US. "We are excited to take this significant step as we continue to advance our mission to bring innovative hearing solutions to underserved markets," said Brent Lucas, Envoy Medical's Chief Executive Officer. "We believe that Envoy Medical is now the leading hearing health company primarily listed on a US stock exchange. For us, NASDAQ was the obvious choice for trading platform. They are home to some of the most successful technology companies improving the world and is the right fit for Envoy Medical." Envoy Medical's primary competitors, such as Cochlear Limited (ASX) and Sonova (SWX), have their primary listings on foreign exchanges. Additionally, Envoy Medical management will attend this year's American Academy of Otolaryngology conference September 30th-October 4th in Nashville, TN. This conference hosts many of the best and brightest otolaryngologist-head and neck surgeons from across the globe. Envoy Medical will be discussing the technological progress and the pathway to its pivotal clinical trial planned for 2024. "Attending the Academy of Otolaryngology conference provides our team the opportunity to discuss our fully implantable cochlear implant design with leaders in the field of hearing health," said Mr. Lucas. "We believe that keeping these medical professionals current with our progress will help speed market acceptance once clinical trials are complete." Management will also attend and hold investor meetings at the LD Micro Main Event Conference in Los Angeles on October 4, 2023. Investors interested in meeting with management should contact Envoy Medical's Investor Relations team. About Envoy Medical Envoy Medical Inc (NASDAQ: COCH), headquartered in White Bear Lake, Minnesota, is a hearing health company focused on providing innovative medical technologies. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to provide patients with improved access, usability, independence and quality of life. About the Fully Implanted Acclaim® Cochlear Implant We believe the fully implanted Acclaim Cochlear Implant is a first-of-its-kind cochlear implant. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim is expected to only be indicated for adults who have been deemed adequate candidates by a qualified physician. The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019. We believe the Acclaim was the first hearing-focused device to receive Breakthrough Device Designation and may still be the only hearing focused medical technology to receive the designation. CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by United States law to investigational use. Important safety information for the Esteem can be found at: . Additional Information and Where to Find It Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at . Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operational improvements and capital investments, clinical testing timeline and results, operational performance, future market conditions or economic performance and developments in the capital and credit markets, as well as any information concerning possible or assumed future operations of Envoy Medical. Forward-Looking statements also include statements regarding the expected benefits of the Nasdaq listing. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the transactions and events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to Envoy Medical's performance following the Business Combination; changes in the market price of shares of Envoy Medical's Class A Common Stock; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Registration Statement on Form S-4 (File No. 333-271920) filed by Envoy Medical (then known as Anzu Special Acquisition Corp I), and in other reports Envoy Medical files with, the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical. ### Investor Contact: Matt Kreps Darrow Associates Investor Relations (214) 597-8200 mkreps@darrowir.com To view the source version of this press release, please visit

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Angina Pectoris	Phase 2	-	Angiogenix, Inc.	-
Angina Pectoris	Phase 2	-	Nitrosystems	-
Angina Pectoris	Phase 2	-	-	-

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