List of Therapeutic Companies in Minnesota - 49

Alpheus Medical, Inc, is a privately held company based in Oakdale, Minnesota, developing a novel sonodynamic therapy platform targeting solid body cancers. The company's lead product utilizes a novel, non-invasive drug device combination for outpatient treatment of recurrent glioblastoma multiforme (rGBM). Alpheus Medical's work has been developed in conjunction with some of the most accomplished names worldwide in neuro-oncology, and with support from the American Cancer Society and National Brain Tumor Society.

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by scaling up our Rare Disease business through the successful launch of our lead asset, Purified Cortrophin® Gel, strengthening our generics business with enhanced research and development capability, innovation in established brands and leveraging our U.S. manufacturing capabilities. For more information, please visit our website www.anipharmaceuticals.com.

Aurora Pharmaceutical - We are creating the products you want by using innovative, state-of-the-art, environmentally friendly technologies. … Devoted to the development of innovative products •Improved formulations utilizing state-of-the-art ingredient technologies •Committed to taking advantage of sustainable green technologies •Enhanced product performance •Engineered for competitive advantage in the marketplace •Science-based marketing support for our trading partners

BlueAllele is working to address the unmet therapeutic challenges in gene editing. Our approach is based on the core principles of innovating and developing the next level of safe and effective treatments for patients with genetic disorders. Our team excels at correcting genes at the DNA level, and has core strengths to move the field forward and develop new therapies.

Celcuity is a clinical stage biotechnology company that discovers previously undetectable cancer drivers and develops drugs to treat them.

CVRx is a commercial stage, public (NASDAQ: CVRX) medical devices company located in Minneapolis, Minnesota. The company has developed proprietary implantable technology for the treatment of high blood pressure and heart failure. Barostim™ triggers carotid baroreceptors - the body's own natural blood flow regulation system - which signals the brain to regulate cardiovascular function. Patient Stories on CVRx: The accounts and quotes of patients are genuine and documented. These stories represent a unique individual experience and does not provide any indication, guide, warranty or guarantee as to the response other people may have to CVRx technologies. Barostim is a prescriptive device. For a list of all potential benefits and risks go to www.cvrx.com/benefit-risk-analysis/

Cytotheryx is a platform technology company focused on the development of a high-quality, consistent source of primary human hepatocytes (PHH), the functional cells of the liver. Based in Rochester, Minnesota, Cytotheryx is using innovative technology to increase the supply of available cells for use by pharmaceutical companies, biotechnology companies, and academic research institutions. Primary human hepatocytes are used widely in research, making them vital to continued scientific and therapeutic breakthroughs. However, a limited supply of liver cells prevents ongoing growth. Cytotheryx is opening doors for how we treat liver disease, develop therapeutics, advance research, and beyond.

DiaMedica Therapeutics is a clinical-stage biopharmaceutical company that is developing innovative treatments where there is significant unmet clinical need or where no current therapies are available with the focus on neurological and kidney diseases.

Endogenex, in partnership with Mayo Clinic, aims to revolutionize treatment options for individuals with type 2 diabetes (T2D). Endogenex's innovations focus on resetting the body's metabolic signaling system by harnessing its natural regenerative capabilities to improve metabolic function. Through the development of the ReCET System and the novel application of precise, controlled, non-thermal pulsed electric fields, Endogenex is establishing a new era in treatment options for people living with T2D, helping patients regain control of their blood glucose levels and slow disease progression. Endogenex is a privately held, clinical-stage company based in Minneapolis, MN.

Overactive bladder (OAB) affects over 15 million women in the US. The sudden, urgent desire to pass urine greatly limits quality of life. Current treatments are not optimal, requiring frequent, time-consuming office visits, awkward vaginal probes, medications with potential side effects or surgery. Those suffering with OAB often consider the therapies too cumbersome and forgo treatment, opting instead to place limits on their life to accommodate the symptoms. Neuromodulation for OAB involving electrical stimulation of the sacral nerve is a proven and established therapy. However, despite being commercially available for over a decade only a small fraction of indicated patients have been treated. The cost and invasiveness of the surgery are often cited as concerns by prospective recipients. FemPulse has developed a novel, wearable medical device designed to deliver neuromodulation therapy directly to the nerves that regulate bladder function, without the need for surgical implant. The small device is easily placed by the patient herself and controlled with a smartphone app. The company is currently conducting clinical evaluations in the United States.

Geneticure optimizes prescription drug therapy by using patients’ DNA to guide their blood pressure treatment with a new, actionable tool, supported by clinical evidence to help you provide even better care for your hypertension patients.

Humanetics is a privately held, clinical stage pharmaceutical company located in the Minneapolis metropolitan area. Our lead candidate, BIO 300 is being developed for multiple clinical uses with a primary focus on improving treatment of solid tumor cancers. BIO 300 is being developed as an agent to both sensitize tumor cells to enhance radiation treatment efficacy and to protect normal tissues from harm. Thus, reducing common treatment related side effects such as radiation induced pneumonitis, erectile dysfunction, mucositis and xerostomia. BIO 300 is also under development for inflammatory lung diseases with an immediate focus on mitigation of pulmonary injury due to COVID-19. A recent contract from NIAID will fund a phase 2 study on BIO 300 in recovering COVID patients in an effort to stem progressive long-term lung complications, such as fibrosis. BIO 300 was licensed from the US Department of Defense, where it was originally developed to prevent injuries associated with ionizing radiation. This program is still underway with a focus on prevention of acute radiation syndrome as well as lung injury. For more information about Humanetics, please visit our corporate website at www.humaneticscorp.com.

IGF Oncology, LLC Our Mission: IGF Oncology is developing novel cancer drugs that have better efficacy and lower side effects than existing cancer chemotherapy drugs.

InSitu Biologics is an emerging biotech company focused on development of a multi-phase prolonged release drug delivery platform for localized treatment of pain, cancer, and infection. We use disruptive technology to address unmet needs in the pain management and drug delivery markets.

LEAH Laboratories is a biotechnology company that specializes in building living therapies for pets and their people.

Luminary is a clinical stage CAR-T therapy company with a novel allogeneic manufacturing platform where our CAR and or TCR development utilizes gamma delta cells. What makes our allogeneic therapeutics unique are that our final drug product includes the combinatory power of both the Vẟ1 and Vẟ2 gamma delta cells giving our therapies the power of both innate and adaptive cancer clearing power. We have multiple solid tumor targets under development with a proprietary signaling method to ensure T-Cell persistence. Additionally, our Ligand BAFF CAR for hematologic cancers is designed with 3 antigen receptors specifically designed to overcome antigen escape.

Melodi Health offers novel technologies that improve patient outcomes for women undergoing breast surgery. Melodi Health manufactures the Melodi Matrix, designed to support the soft tissue space around a prosthetic device while delivering antibiotics to the surrounding tissue. The Melodi Matrix is currently an investigational device being studied in a prospective, multi-center, randomized, controlled clinical trial in breast reconstruction.

Headquartered in Minneapolis, Minnesota, Metavention, Inc. is a privately held medical device company developing novel treatments for metabolic diseases

What we know: - Currently, 106,000 people in the U.S. are on the waitlist for a life-saving organ transplant. - 60% of patients on the waitlist will not receive the organ they need. - 17 people in the U.S. die each day due to the lack of available organs. What we're doing: Miromatrix Medical was founded with the mission to eliminate the transplant waitlist. Headquartered in Eden Prairie, Minnesota, we bioengineer organs through our patented perfusion decellularization and recellularization technology. We take what nature designed -- a fully functioning liver or kidney -- and with our patented technology, remove all of the cells from discarded pig organs. What's left is a ‘scaffold'; all of the organ's natural design and architecture remains. Then, from the inside out, we seed new, living human cells back into the organ -- ultimately creating completely functional, transplantable organs with the potential to save thousands of lives every year.

Monteris is a private equity backed neurosurgical company focused solely on diseases of the brain. The company was founded in Winnipeg, Canada in 1999 to create neurosurgical technology that, when used by neurosurgeons, would allow them to ablate brain tumors and lesions that may be difficult to approach via traditional methods. The NeuroBlate® System is a minimally invasive robotically controlled laser thermal therapy that uses MRI-guided laser light to ablate (destroy) unwanted tissue in the brain where a lesion, or abnormal tissue, originates. Monteris has offices in Minnetonka, Minnesota, USA and Winnipeg, Manitoba, Canada.

Morari's objective is to restore confidence in male sexual health by eliminating the embarrassment and frustration of premature ejaculation (PE). PE is the most prevalent male sexual dysfunction, estimated to affect 30% of men worldwide. With a higher incidence than erectile dysfunction or an enlarged prostate, men rarely talk about it or seek treatment. The Morari product concept would allow the male who desires a delay in ejaculation to use an external device that when activated by either partner, would use neuromodulation techniques to interfere with nerve signals to delay an ejaculation. When deactivated, the elements would not interfere with nerve signals.

Applied NanoBiology™ is the intersection between nanotechnology and biology. Artoss scientists apply their knowledge of physics and biology to create new nanostructured biomaterials for bone repair. This represents A New Dimension in Bone Repair™. Artoss, Inc. currently distributes NanoBone® advanced bone graft products in the United States. NanoBone Granules and NanoBone SBX Putty have been used successfully in 400,000 cases over the past ten years in Europe and US. NanoBone performs as well as the competing gold standards for bone grafting, with lower complications than autograft. Our German partner, Artoss GmbH, has multiple issued and pending patents to protect the technology. Artoss intends to develop and introduce multiple proprietary forms of NanoBone to address specific clinical needs. This includes the use of NanoBone as an implant coating to improve osteointegration of joint replacements and spinal fusion implants.

NeuroOne Medical Technologies is a medical device company that specializes in developing high-definition, minimally invasive thin film electrodes for the diagnosis and treatment of various neurological conditions.

Nuvaira was established in 2008 to address unmet clinical needs in the treatment of overactive airway nerves, a common disease feature of both COPD. The company offers innovative COPD therapies to help preserve patient lung health with a catheter-based system used to treat overactive airways.

We are Nuwellis, (Nasdaq: NUWE) formerly CHF Solutions. Our solutions go beyond chronic heart failure, so we've rebranded to reflect our therapeutic focus areas: heart failure, critical care, and pediatric fluid imbalance. We are a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. Our Aquadex SmartFlow® System gently removes fluid from adult and pediatric patients weighing 20 kg or more. Nuwellis consists of a purpose-driven team that puts patients and their providers at the center of everything we do. This is the new well. And for those whose lives and life's work are transformed by our fluid management technologies, the new well is everything. Nuwellis is headquartered in Eden Prairie, Minn., with a wholly-owned subsidiary in Ireland. The Company has been listed on the Nasdaq Capital Market since February 2012, previously branded as CHF Solutions (Nasdaq: CHFS).

Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for urgent unmet medical needs. The company's current focus is on the treatment of urgent unmet medical needs.

The number of patients requiring hemodialysis is expected to reach 774,000 with an annual incidence of more than 160,000 new patients per year who require vascular access for hemodialysis. Vascular access for hemodialysis is creating a special pathway in the body to cleanse the blood when the kidneys aren't working (End Stage Renal Disease). Two methods of permanent vascular access: Arteriovenous Fistula (AVF) Arteriovenous Grafts (AVG) Phraxis, Inc is a Minneapolis MN based company that has developed the EndoForce™ Venous Anastomotic Connector to provide a procedural technique for AVG implantation that may lessen the neointimal hyperplasia-induced stenosis that is associated with conventional sutured venous anastomosis. See our complete clinical study of the EndoForce™ Venous Endovascular Anastomotic Connector here: https://pubmed.ncbi.nlm.nih.gov/36895157/ And join the movement at www.phraxis.com as we seek FDA approval. The EndoForce™ Venous Anastomotic Connector is an investigational device. Limited by Federal (United States) law to investigational use.

Ponte Biosciences, Inc. is a preclinical biotherapeutic company focused on developing a cell-based bioartificial liver system to treat acute forms of liver failure. The Company's Spheroid Reservoir Bioartificial Liver (SRBAL) system was developed at the Mayo Clinic and utilizes metabolically active primary hepatocytes (liver cells) to replace and/or supplement liver function for patients with liver failure being treated in the Intensive Care Unit (ICU).

Our mission at Predictive Oncology is to change the landscape of oncology drug discovery and enable the development of more effective therapies in the treatment of cancer. By harnessing the power of machine learning, scientific rigor and biologics, we can improve the probability of success and advance drug compounds with a higher degree of confidence. We invite you to follow us to stay up-to-date about our latest developments.

Recombinetics is a global leader in proprietary gene repair and gene-editing technology. Our breakthrough scientific research and development of TALEN and CRISPR (Cas9) gene editing technologies has resulted in breakthroughs in the regenerative medicine, disease research and animal agriculture. Led by a team of expert geneticists, genome engineers, and reproductive physiologists, the company is headquartered in St. Paul, Minnesota.

RespirTech, a Philips company, works with healthcare teams, patients and caregivers to provide effective airway clearance therapy with the Philips InCourage system and Philips Respironics CoughAssist T70. Our dedicated customer care team contributes to improved management of chronic respiratory conditions like cystic fibrosis, COPD, bronchiectasis and certain neuromuscular and neuromotor diseases. RespirTech's innovative products and exceptional service supports patients on their journey to better breathing. Respiratory Technologies, Inc., dba RespirTech, was founded in 2004 and acquired by Philips in 2017.

Rion is a clinical-stage regenerative medicine company focused on developing innovative exosome therapeutics that are clinically impactful, accessible, and practical for any patient, anywhere. Rion has developed Purified Exosome Product (PEP), an innovative biologic platform that optimizes the therapeutic power of exosomes for regenerative medicine.

RxFunction®, Inc. is a medical device company with a mission to design and market medical technologies that improve balance, increase mobility, and enhance confidence for patients. Walkasins® Lower Limb Sensory Prosthesis is clinically proven to improve gait and balance, and reduce the risk of falls. Walkasins replaces part of the lost nerve function for the feet. It is intended for individuals who experience numbness in their feet and struggle with mobility problems due to peripheral neuropathy. Walkasins is only available by prescription. To learn more, please visit us at www.rxfunction.com. RxFunction created Walkasins by building upon patented technology developed by co-founder and scientist Lars Oddsson, PhD. Development of Walkasins was supported by Small Business Innovation Research grants from the National Institutes of Health and is manufactured in Minnesota. RxFunction is the exclusive provider and manufacturer of Walkasins. Caution: Individual results and activity levels while using Walkasins may vary depending on many factors. There are risks associated with the use of this product and there are certain individuals who should not use the product. Only a qualified clinician can tell you if this product is appropriate for you and your individual circumstances. Please consult with your healthcare team for complete information regarding benefits, risks, and possible outcomes.

As an emerging leader in the development and commercialization of energy transfer technology, SANUWAVE® presents products that help expedite wound healing on a cellular level. SANUWAVE's easy-to-use ENERGY FIRST® product portfolio works to help heal some of the most difficult, stalled, or hard-to-heal wounds by activating the body's normal regenerative process using an assortment of energy waves, from shockwaves to ultrasound. SANUWAVE values patient comfort and the importance of wound healing, recognizing its' value to not only improve patient quality of life but to help avoid further complications that could lead to amputation or even lives lost. SANUWAVE's minimally to completely non-invasive technologies can help wounds heal with little to no pain or discomfort. Most treatments can be done in under ten minutes, however, results may vary depending on wound size and patient response to treatment. The UltraMIST System delivers low-frequency ultrasound to the treatment site using a noncontact fluid (e.g., saline). MIST Systems produce a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of fibrin, yellow slough, tissue exudates, and bacteria. The MOA includes control of inflammation, augmentation of local tissue perfusion, wound bacteria and bacterial biofilm reduction, increased angiogenesis, and more. The dermaPACE System is an advanced wound care device that utilizes pulsed acoustic cellular expression (PACE®) technology, a proprietary form of focused, extracorporeal shockwaves. It is the first shockwave system to be FDA-cleared for the treatment of diabetic foot ulcers (DFU). For general inquiries, please email: info@sanuwave.com

SecondWave Systems is a pioneer in the emerging field of bio-ultrasonic medicine. The company is developing a first-of-its-kind noninvasive, wearable ultrasound stimulation platform that will give patients and their physicians a new option for treating debilitating or life-threatening disease.

ShiraTronics is a forward-thinking medtech startup committed to revolutionizing the field of migraine medicine with our minimally invasive neuromodulation system. Our mission? To transform the lives of those facing Chronic Migraine by reducing headache days and restoring quality of life.

SilkTech Biopharmaceuticals develops silk-based anti-inflammatory therapies. Our lead indication is in Dry Eye Disease, an inflammatory based chronic condition.

ABOUT SONEX HEALTH "Refined simplicity" is the guiding principle behind Sonex Health, Inc., to drive efforts and innovations that result in elegant, effective solutions to some of the healthcare system's most pressing needs. Mayo Clinic physicians Darryl Barnes, MD and Jay Smith, MD and business operations expert Aaron Keenan founded Sonex Health in 2014. Sonex Health has developed UltraGuideCTR™ with Meerkat Technology™ to treat carpal tunnel syndrome through a less invasive approach while using real-time ultrasound guidance. Carpal Tunnel Release with UltraGuideCTR and real-time ultrasound guidance allows a procedure that once took place in an operating room to be safely and effectively performed in a surgery center or office setting, resulting in rapid patient recovery, improved cosmesis, and reduced costs. ABOUT UltraGuideCTR The low profile UltraGuideCTR™ with Meerkat Technology™ enables physicians to perform Carpal Tunnel Release surgery through a small wrist incision under real-time ultrasound guidance. CTR with ultrasound guidance relieves the symptoms of carpal tunnel syndrome while minimizing recovery time. Most patients can return to work and the activities in 3-6 days while enjoying immediate motion so they can focus on getting back to their lives and the activities they love. ABOUT UltraGuideTFR Performing trigger finger release with UltraGuideTFR and real-time ultrasound guidance allows for concurrent visualization of the internal structures of the palm and fingers. The ability to identify key anatomical landmarks via ultrasound supports a safe and successful transection of the pulley through a single small incision.

Spineology's OptiMesh is the only conforming, patient specific lumbar expandable implant on the market. OptiMesh is delivered through the smallest insertion profile, dynamically conforms to a patient’s unique endplate morphology, and powerfully expands to one of the largest implant footprints available. Spineology’s OptiMesh features our unique Conform and Expand™ technology, enabling a custom anatomical fit for lumbar fusion surgical patients. OptiMesh is designed to overcome the challenges of static and mechanically expandable implants.

SpineThera designs and develops sustained-release, injectable drugs to meet the unique safety requirements for administration in and near the spine. Our proprietary drugs offer patients and physicians new treatment options that reduce risk, improve outcomes, and manage overall treatment costs in markets with few or no approved drugs.

SpineThera designs and develops sustained-release, injectable drugs to meet the unique safety requirements for administration in and near the spine. Our proprietary drugs offer patients and physicians new treatment options that reduce risk, improve outcomes, and manage overall treatment costs in markets with few or no approved drugs.

Stimdia Medical, Inc., is a privately held company headquartered in Minneapolis, MN and has developed the pdSTIMTM System, a minimally invasive, temporary, neuromuscular stimulation system which has received FDA Breakthrough Device Designation. Mechanical ventilation (MV) is considered to be a lifesaving treatment in patients suffering respiratory failure to achieve sufficient pulmonary gas exchange. However, prolonged MV can promote atrophy and contractile dysfunction of the primary muscle utilized in respiration, the diaphragm. Significant loss in muscle mass results in a reduction in diaphragmatic function and compromises the ability of patients to breath on their own. The pdSTIM System was designed to awaken and restore the integrity of the diaphragm muscle in patients who are on MV. This is accomplished with the use of subcutaneously inserted temporary leads connected to the pdSTIM console and utilizes the proprietary RespiSyncTM sensing and stimulation algorithms to coordinate phrenic nerve stimulation with physiologic diaphragmatic movement in synchrony with mechanical ventilators. The pdSTIM System has not yet received regulatory clearances or approvals and is not currently for sale in any country.

Surmodics is the global leader in surface modification technologies for intravascular medical devices and a leading provider of chemical components for in vitro diagnostic (IVD) immunoassay tests and microarrays. Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements.

CAUTION -– Investigational device. Limited by Federal (or United States) law to investigational use. SynerFuse is long-term pain management without the use of addictive opioids. SynerFuse combines two FDA-approved technologies and synergistically fuses both in order to attack the problem of long-term, post-surgery, lower back pain, with a preemptive, drug-free pain management system.

Syntiron LLC, is dedicated to developing innovative vaccines for humans. Our patented microbial antigen discovery and purification technology targets proteins that acquire iron, a critical nutrient that is required for survival of the bacteria. These proteins are expressed on the cell surface and are similar among different strains, making them ideal vaccine antigens. Our proprietary platform enables rapid identification of these proteins, which can then be directly extracted from the host cell or produced recombinantly for preclinical vaccine development.

Tychon Biosciences is a biotechnology company commercializing novel technology in the rapidly expanding Immuno-oncology marketplace that offers similar high-specificity cancer killing relative to recently-approved cancer therapies, yet with increased safety and decreased cost. Using Tychon’s BiND platform, a first-in-class bi-specific nanoring platform as an immediate therapy that targets both an antigen receptor on a cancer cell, and T-cell—binding them together and allowing your T-cells to attack cancer cells naturally without the need for genetic engineering.

Valley Tissue Culture is a seed potato company that usesmicropropagation in a sterile laboratory to produce potato seeds.

Vireo was founded as a pioneer in medical cannabis in 2014 and is fueled by an entrepreneurial drive. Vireo subsidiary companies cultivate and manufacture a wide variety of high-quality cannabis strains and products for sale through wholly-owned retail dispensaries and licensed third-party dispensaries, with a relentless focus on delighting customers and serving the communities in which we live and operate.

Vyriad is a biotechnology company that develops targeted genetic therapies using engineered viruses and viral vectors for oncolytic virotherapy and gene editing applications.