DENTON, TEXAS, USA – November 15, 2023 The US Food and Drug Administration (FDA) has granted over-the- counter marketing clearance for the ManaFlexx 2®, an Electrical Stimulation (EMS) device, from MANAMED®, LLC. ManaFlexx 2 is a compact medical device that delivers electrical pulses to the user’s skin through the company’s patented wireless technology for two distinct uses. The expanded indication applies to both ManaFlexx 2 device’s indications: Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS).

Unlike conventional EMS systems, ManaFlexx 2 was designed for ease of use; it is a completely portable and wireless device, that may be placed anywhere treatment is desired, it is reusable and rechargeable. The ManaFlexx 2 was originally only available by prescription through a healthcare provider.

Professional and everyday athletes have been appreciating the many benefits of Neuromuscular Electrical Muscle Stimulation (NMES) for years. Electrostimulation therapy isn’t new technology – NMES has been used to stimulate healthy muscles in order to improve muscle and facilitate muscle performance. It also intended to temporarily increase blood circulation in the healthy muscles of lower extremities. Now weekend warriors and consumers will have increased access to NMES technology.

Transcutaneous Electrical Nerve Stimulation (TENS), is a separate function of ManaFlexx2. The TENS function provides temporary relief of pain associated with sore and aching muscles in the shoulder, waist, arm and leg due to strain from exercise or normal household and work activities . This expanded indication joins the previous FDA clearance granted for the noninvasive device as an adjunctive treatment in the management of post-surgical and post- traumatic acute pain.

“Our goal was to make both NMES and TENS simple and practical for professionals and non-professionals alike”, explained MANAMED President and CEO, Trevor Theriot. “Now with the over-the-counter clearance for ManaFlexx 2, we have an ideal solution to increase access for the at-home user who seeks the benefits of NMES for improved muscle performance or TENS for symptomatic relief and management of chronic pain, intractable pain and relief of pain associated with arthritis.”

The US Food and Drug Administration (FDA) has granted over-the- counter marketing clearance for the ManaFlexx 2®, an Electrical Stimulation (EMS) device, from MANAMED®, LLC. ManaFlexx 2 is a compact medical device that delivers electrical pulses to the user’s skin through the company’s patented wireless technology for two distinct uses. The expanded indication applies to both ManaFlexx 2 device’s indications: Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS).

Novel Device Now Available Without a Prescription

MANAMED Receives Expanded 510(k) Clearance for ManaFlexx 2

LAS VEGAS (February 23, 2022) – ManaMed Inc., a leading provider of orthopedic devices that range from bracing, soft goods, electrical stimulation and vascular therapy devices, and the UFC Performance Institute (UFC PI), the world’s leading high-performance service provider for mixed martial arts (MMA) athletes, today announced a multi-year partnership in which ManaMed products will be made available to UFC athletes who utilize UFC PI services.

Under terms of the agreement, ManaMed is named an Official Partner of the UFC Performance Institute and will provide UFC athletes access to high quality orthopedic braces, soft goods, and a personalized “Fight Night” recovery kit with key splinting and stabilizing essentials, such as crutches, knee braces and walking boots.

“We have always wanted to partner with high performance athletes, elevate their care, and provide them with products that help them return to action quicker,” said ManaMed President and CEO, Trevor Theriot. “The UFC PI is one of the most forward-thinking sports research and performance organizations worldwide, and we are honored to partner with them at their facilities in the United States and China.”

This partnership is the first of many steps toward ManaMed’s future growth and integration into the professional sports and athletics industry. In working with UFC PI in China, ManaMed is also jumpstarting its goal of expanding its business and becoming the leading international provider of orthopedic devices.

“UFC would not be the sport it is today without the passion our athletes bring, which is why their health and performance is our top priority,” said UFC Director of Physical Therapy, Heather Linden. “We look forward to working with ManaMed to provide our athletes with high-quality products that will help them safely get back to the Octagon sooner.”

The leading device company will provide UFC athletes with high-quality orthopedic products.

ManaMed Inc. Named Official Partner of the UFC Performance Institute

DENTON, Texas, Oct. 13, 2022 /PRNewswire/ -- ManaMed strives to be at the forefront of medical innovation, which is why it is excited to announce that its DVT prevention device, PlasmaFlow, has just received UnitedHealthcare coverage.

 PlasmaFlow is a wearable and portable prescription device that helps prevent blood clots during surgery, at discharge, and at home. It has been shown to increase patient awareness and safety about blood clots while also reducing the risk of pulmonary embolism, and ManaMed is proud to offer this life-saving technology to all medical institutions and providers who are committed to protecting their patients from potential harm. With PlasmaFlow, ManaMed is confident that it can make a difference in the lives of those who need it most.

ManaMed's CEO and president, Trevor Theriot, says, "UnitedHealthcare's policy update is game-changing for PlasmaFlow. It has been in the market for over 6 years and nearly one million patients have benefited from this medical device. We believe that this March policy update will provide greater access to current UHC patients but will also cause other commercial payers like Anthem to update or re-evaluate their existing medical policies for pneumatic compression devices. As we continue to hear success stories from both providers and patients using this cutting-edge technology, it's hard not to get excited about the future of ManaMed and how we are going to change the lives of even more people."

ManaMed's Vice President of Sales, Joseph Horton, says, "UHC has recognized some key factors that are associated with risk of DVT post-operatively upon discharge. Those key factors include immobility and contraindication to pharmaceutical-anti coagulation due to the risk of bleeding. Based upon my experience, UHC may be looking at the readmission rates provided by CMS along with the risk of developing a DVT can extend at least up to 3 months after surgery. Key evidence of the second peak of development for a DVT can occur about 10 days after surgery; this is when most patients have already been discharged from a facility."

PlasmaFlow is the only FDA-approved prescriptive portable DVT pump with two therapeutic modalities that apply 55mmHg: the first mode applies pressure up to 55mmHG once a minute, and the second mode, which is ManaMed's patented step-up inflation applies, 55mmHg in intervals of 10mmHg for a full minute, which allows for continuous compression to the lower extremities. Functioning as an easy-to-use Intermittent Pneumatic Compression (IPC) device, PlasmaFlow consists of two inflatable sleeves that are wrapped around the calves and secured by a hook and loop closure.

Once inflated, the device will compress the leg(s) and will increase blood circulation while reducing Venous Stasis, which will reduce the risk of a blood clot(s). PlasmaFlow is a remarkable device that provides patients with a convenient and comfortable way to prevent DVT. With its two therapeutic modes, patients can choose the mode of compression that is right for them.

PlasmaFlow is easy to use, and its portability makes it ideal for those who are constantly on the go. Whether you are at risk for DVT or have an upcoming surgery, PlasmaFlow can help you keep your blood flowing and increase your chances of being clot-free.

IPC has been proven over the last 30-plus years with clinical studies to reduce the risk of DVT (Blood Clots) with significantly no side effects by increasing blood circulation and reducing venous stasis. Clinical studies have shown that wearing an IPC Device will stimulate the release of the body's own natural anticoagulants to help prevent the development of a potentially life-threatening blood clot(s).

UnitedHealthcare Policy Number 2022T0563M

Intermittent limb compression devices have been proven to be medically necessary for outpatient settings and upon discharge of a patient post-surgery. PlasmaFlow efficiently prevents deep venous thrombosis (DVT) if the following criteria are met:

Immobility, meaning a patient is not able to get up from a chair or leave his/her bed and walk to the toilet without the help of another person

Contraindication to pharmaceutical anti-coagulation

None of the following contraindications are present:

Skin or tissue conditions that may be negatively impacted by the use of garments

ManaMed strives to be at the forefront of medical innovation, which is why it is excited to announce that its DVT prevention device, PlasmaFlow, has just received UnitedHealthcare coverage.

Cutting-Edge PlasmaFlow Device Receives UnitedHealthcare Coverage

ManaMed (ManaMed.com) is proud to announce the U.S. Food and Drug Administration (FDA) approval for the ManaSport™ ultrasound therapy Class II device. The ManaSport™ device, is a new ultrasound therapy device that provides pain relief and treatment for soft tissue injuries and is popular among athletes and sports professionals. Safe and easy to use, the new device is set to offer life-changing support to those suffering from ongoing issues. FDA approval has now cleared the product for a range of indications for use, including:

Relief from pain and joint contractures associated with adhesive capsulitis, bursitis with slight  calcification, myositis, soft tissue injuries, and shortened tendons from past injuries and scar tissue

Relief from pain and muscle spasms resulting from capsular tightness and capsular scarring

Increasing the range of motion of contracted joints with heat and stretch techniques

Portable and rechargeable, the device can now be prescribed by medical professionals and is intended for supervised use. It provides non-invasive pulsed ultrasound therapy at localized sites through ultrasound gel, with no discomfort to the patient. A complete therapy session takes just 20 minutes, and  the product comes complete with everything you need to carry out therapy sessions, including ultrasound gel, a strap to hold the applicator in place, and a battery charger.

This compact medical device has an intuitive display with simple instructions for use. A built-in calendar helps users stay on top of treatments, while special safety features can lock the device to avoid unintended operation. Physicians and physiotherapists can manually move the applicator throughout  the affected area, or use the included strap for a static, hands-free treatment.

Put simply, ManaSport™ provides a straightforward and effective solution for many medical and sports related issues and conditions, without the need for surgery or opioids. With the new FDA approval,  ManaSport™ is sure to become the go-to therapy for sports medicine doctors everywhere.

Trevor Theriot, President, and CEO commented, "ManaMed will continue to design, develop, and  innovate the entire Med Tech space. ManaSport™ demonstrates our commitment to invest in the future  and expand our access to the entire continuum of care."

ManaMed (ManaMed.com) is proud to announce the U.S. Food and Drug Administration (FDA) approval for the ManaSport™ ultrasound therapy Class II device. The ManaSport™ device, is a new ultrasound therapy device that provides pain relief and treatment for soft tissue injuries and is popular among athletes and sports professionals.

Manamed, a pioneering Medical Technology development company, has been granted FDA approval on 
its latest orthopedic recovery device, ManaSport.

Revolutionary Wearable Ultrasound Device Gains FDA Approval

ManaMed™ Inc., a leading provider of orthopedic devices, is proud to announce its ranking on Inc. 5000, the most prestigious ranking of the nation's fastest-growing private companies. The list represents a unique look at the most successful companies within the American economy's most dynamic segment—its independent small businesses. 

"We are honored to be named one of the fastest growing companies in America," said ManaMed CEO, Trevor Theriot. "I started this company in 2015 with a vision to be a market leader in the healthcare space. Six years later, I could not be prouder of our team – this rank is a true reflection of their tireless work and dedication."

With locations spanning acrossNevada andTexas, ManaMed provides orthopedic devices, that range from bracing, soft goods, electric stimulation, and vascular therapy devices. The company is the largest supplier of portable DVT prevention devices, with our brand name PlasmaFlow™ holding the market leading position. ManaMed's core initiatives fit into its focus to drive better clinical outcomes with quality patient care and innovative medical devices.

Complete results of the Inc. 5000, including company profiles and an interactive database that can be sorted by industry, region, and other criteria, can be found at www.inc.com/inc5000.

"The 2021 Inc. 5000 list feels like one of the most important rosters of companies ever compiled," says Scott Omelianuk, editor-in-chief of Inc. "Building one of the fastest-growing companies in America in any year is a remarkable achievement. Building one in the crisis we've lived through is just plain amazing. This kind of accomplishment comes with hard work, smart pivots, great leadership, and the help of a whole lot of people." 

ManaMed™ Inc., a leading provider of orthopedic devices, is proud to announce its ranking on Inc. 5000, the most prestigious ranking of the nation's fastest-growing private companies.

North Texas-based medical device company ranks as one of the nation's fastest growing companies.

ManaMed Ranked No. 992 on the 2021 Inc. 5000 With 485% Three-Year Revenue Growth

The company's historical first FDA-approved portable and tubeless DVT prevention device is now available to medical practitioners and patients throughout the United States. 

"We at ManaMed are thrilled that our innovative PlasmaFlow DVT prevention device is available to help mitigate the risk to 600,000-plus new cases of DVT every year in the USA," says Trevor Theriot, Co-Founder and CEO of Manamed.  Theriot adds: "Blood Clots are a silent killer in the medical industry and we decided to up the fight against DVT related deaths."  PlasmaFlow is the first FDA-approved portable and tubeless sequential device with multiple pressure functions. Designed for optimal results and patient comfort, PlasmaFlow features innovative step-up-technology, user-friendly one-button operation, soft cuffs made of high-grade medical material, up to 10hours of battery life, rechargeable, two LCD screens with timer and verification of pressure, and graduated and asymmetric compression for maximum benefit.

A thriving demand for ease in treatment is provided by PlasmaFlow.  Tubeless and portable, PlasmaFlow is intended for use at home or at the hospital to help prevent the onset of DVT in patients by stimulating blood flow in the extremities. PlasmaFlow can be used to prevent DVT, enhance blood circulation, reduce post-operative pain and swelling, reduce wound healing time, aid in the treatment of  stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiently and reduction of edema in the lower limbs. The device can also be used as an aid in the prophylaxis for DVT by people stationary for long periods of time. 

The risk of getting a blood clot is highest during and 14 days after surgery, and goes down with time. PlasmaFlow should be used anytime during post-surgery recovery when a patient is sitting, resting or laying down. PlasmaFlow, prescribed by a physician, allows a multimodal approach for venous thromboembolism (VTE) for high-risk orthopedic surgery patients. Current Board guidelines indicate that aspirin is not appropriate as the only option for the prevention of DVT. Unlike prescriptive drugs, PlasmaFlow helps mitigate the risk of bleeding and does not require weekly blood monitoring. 

Theriot adds: "With our FDA approval we feel PlasmaFlow is a great leap for mankind toward DVT prevention and we will remain on the cutting edge toward pioneering a wide range of innovative physical therapy devices all geared toward making daily life a better experience for all."

News Room

MANAMED Receives Expanded 510(k) Clearance for ManaFlexx 2

Revolutionary Wearable Ultrasound Device Gains FDA Approval

Cutting-Edge PlasmaFlow Device Receives UnitedHealthcare Coverage

ManaMed Inc. Named Official Partner of the UFC Performance Institute

ManaMed Ranked No. 992 on the 2021 Inc. 5000 With 485% Three-Year Revenue Growth

ManaMed Inc. Introduces PlasmaFlow, The World's First FDA-Approved Digital and Tubeless Deep Vein Thrombosis Prevention Device

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