Press Release

BioWorld-MedTech – July 2017

Throwback device moving back to the forefront

Trina Health, Animo’s ‘pump’ shown to be effective at mimicking pancreatic function

By Omar Ford, Staff Writer

A device developed more than two decades ago could finally be used as an effective treatment in diabetes.Trina Health Midwest LLC’s Bionica Microdose pump was demonstrated to “closely replicate” normal pancreatic function, results from a study published in the July edition of The Journal of Diabetes, Metabolic Disorders & Control show.

The study, titled “Microburst insulin infusion: results of observational studies – carbohydrate metabolism, painful diabetic neuropathy, and hospital/emergency department utilization,” looked at more than 2,000 patients.

The Bionica Microdose pump uses IV infusion to mimic the insulin pulses of a healthy pancreas in what the company calls the Artificial Pancreas Treatment (APT). This in turn stimulates the liver to produce the enzymes necessary for carbohydrate metabolism, which lowers lipid metabolism, resulting in more cellular energy in body tissues.

The process is monitored by frequent glucose levels and metabolic measurements. APT is done over one-hour periods with a rest period between each session for three courses each day of treatment. Typically, APT is performed on a weekly or bi-weekly basis following the first week of two back-to-back daily sessions.

To commercialize the device, which is a little larger than a smartphone, Sacramento-based Trina Health began a partnership with San Clemente, Calif.-based Animo Health Inc., late last year.

“The FDA-approved device was still in use, it just wasn’t commercialized enough to the point where it would start helping people en masse,” Mark Pound, president and CEO of Animo Health, told BioWorld MedTech.

He stressed the device is not a cure for diabetes.

Study results

The study published in The Journal of Diabetes, Metabolic Disorders & Control is based on data from three observational retrospective studies that underscore the effectiveness of microburst insulin infusion.

The carbohydrate metabolism portion of the study suggests APT has a dramatic effect on carbohydrate metabolism; this is of particular importance as the inability to properly metabolize carbohydrates represents a core dysfunction in diabetes.

In the painful diabetic neuropathy portion of the study, among the 412 patients studied over a three month period, APT completely eliminated or significantly reduced pain in 93 percent of the patients.

Finally, in the two-year retrospective hospital and emergency room validation portion of the study, which evaluated 1,524 patients, it was shown that APT significantly reduced the number of hospital and emergency visits. According to Matched National Hospital Discharge Survey and U.S. Agency for Healthcare Statistics, expected hospitalization rate is 94 per 1,000 patients over a two-year period and the study showed the APT rate was five. Expected emergency room visits are 116 per 1,000 patients over two years and the APT rate was seven.

“I think the study points out what we’ve known for a while and we put this together to prove it,” Pound said.

Stepping out of the shadows to take on the competition

Trina Health was formed by Ford Gilbert after it was discovered his daughter suffered from type 1 diabetes in the early 1980s. Gilbert, who was once an attorney, enrolled in medical school, started a nonprofit research institute and eventually created the Bionica Microdose pump. Gilbert’s daughter received the first treatment from the device when she was 5-years-old. Now she is 34-years-old, and has given birth to five children.

“He gave up his legal career and immersed himself in the medical world, specifically in the world of diabetes,” Pound said. “It’s really an amazing story.”

Other products on the market

Other companies such as Dublin-based Medtronic plc and Germantown, Md.-based Senseonics Inc. have made waves with artificial pancreas applications.

Medtronic received FDA approval for its Minimed 670G hybrid closed loop system in September 2016, and launched the device in June. (See BioWorld MedTech, Sept. 30, 2016.)

“It’s not apples to apples,” Pound said when comparing Medtronic’s device and the APT therapy. “There is a difference. What Medtronic calls an artificial pancreas is really a closed-loop glucose monitoring system that is developed subcutaneously. Whereas we’re actually an artificial pancreas treatment.”

There could be tremendous opportunities for companies to compete with Medtronic’s artificial pancreas, said Sean Lavin an analyst with BTIG.

“Of note, from the 700-patient training phase [of Minimed 670G], Medtronic disclosed 83 percent satisfaction with the device and 96 percent satisfaction with the training,” Lavin said. “The device satisfaction is strong, but at 83 percent in a hand-picked group of patients indicates to us that the 670G will not be for everybody.”

Senseonics could see an approval by the beginning of next year.

“We assume a panel and approval near year end, but it could come sooner if the FDA decides not to have a panel,” Lavin said.

Pound said while the competition is much bigger and not much is known about Trina Health, the publication of the data could help bring awareness to the Bionica Microdose pump.

“We’ve already started to see [an increased] interest in the technology,” Pound said

Press Release

Newly Published Study Validates How Trina Health Artificial Pancreas Treatment® Can Reduce Hospitalization Rates/Costs and Reverse Neuropathy

SAN CLEMENTE, Calif. and CHESTERFIELD, Mo., July 26, 2017

—Animo Health, Inc. dba Trina Health Midwest announced today that its Trina Health Artificial Pancreas Treatment (APT) “represents a new advance to the treatment of diabetes, due to its ability to closely replicate normal pancreatic function,” as reported in a just-published study in The Journal of Diabetes, Metabolic Disorders & Control entitled ‘Microburst Insulin Infusion: Results of Observational Studies—Carbohydrate Metabolism, Painful Diabetic neuropathy, and Hospital/Emergency Department Utilization” (Volume 4 Issue 4 2017).

The study is based on data from three observational retrospective studies that underscore the effectiveness of microburst insulin infusion.

“The Microburst Insulin Infusion Study provides a scientific validation to what we see every day in our clinics,” said Mark Pound, president and CEO of Animo Health, Inc. dba Trina Health Midwest. “After several treatments we’ve seen the Artificial Pancreas Treatment slow, stop and even reverse complications associated with Type 1 and Type 2 diabetes. Patients suffering from neuropathy can feel their feet again and become active again. Patients who were constantly fatigued now have new energy. Patients suffering from retinopathy have improved eyesight. Patients nearing dialysis treatment have been told it’s no longer needed. ”

“The Artificial Pancreas Treatment is NOT a cure,” Pound emphasized. “However, it is exponentially improving our patients’ quality of life.” The Artificial Pancreas Treatment, which more closely mimics the natural burst insulin secretion of a healthy pancreas, showed significant improvement in three observational retrospective studies: carbohydrate metabolism, painful diabetic neuropathy (PDN), and hospital/emergency department utilization.

Carbohydrate metabolism study

These results suggest that the Artificial Pancreas Treatment has a dramatic effect on carbohydrate metabolism; this is of particular importance as the inability to properly metabolize carbohydrates represents a core dysfunction in diabetes.

Painful Diabetic Neuropathy (PDN) study

Among 412 patients studied (80 percent Type 2, 20 percent Type 1) over a three-month period, the Artificial Pancreas Treatment completely eliminated or significantly reduced pain in 93 percent of PDN patients.

Hospital and emergency room utilization study

The Artificial Pancreas Treatment dramatically lowers hospital utilization and hospital costs. A two-year retrospective study of 1,524 Type 1 and Type 2 diabetes patients with two or more complications was conducted at 14 centers. The Artificial Pancreas Treatment® (APT) significantly reduced the number of hospital and emergency visits. According to Matched National Hospital Discharge Survey (NHDS) and U.S. Agency for Healthcare Statistics, expected hospitalization rate is 94 per 1,000 patients over a twoyear period. The APTs rate is 5. What’s more, expected emergency room visits are 116 per 1,000 patients over two years. The APT rate is 7.

Conclusion

The study stated: “In summary, conventional insulin therapy has achieved only partial success in the treatment of diabetes and prevention of chronic complications…. Microburst insulin therapy represents a new advance in the treatment of diabetes, due to its ability to closely replicate normal pancreatic function. Taken together, the rather dramatic reductions in neuropathic complications and hospital/emergency department visits, as well as the significant improvements in carbohydrate metabolism in these observational studies, may be due to the more precise mimicking of naturally pulsed insulin.”

A PDF Abstract of “Microburst Insulin Infusion: Results of Observational Studies—Carbohydrate Metabolism, Painful Diabetic Neuropathy, and Hospital/Emergency Department Utilization” can be downloaded at http://medcraveonline.com/JDMDC/JDMDC-04-00118.pdf.

About Trina Health LLC, in Partnership with Animo Health, Inc. dba Trina Health Midwest

With over 200,000 treatments with no adverse reactions and more than 24 domestic and international clinics, the Trina Health Artificial Pancreas Treatment is expanding throughout the United States and abroad. Animo Health, Inc., doing business as Trina Health Midwest, has obtained exclusive rights to establish clinics throughout Missouri and the Midwest using Trina Health’s Artificial Pancreas Treatment that can slow, halt, and/or reverse in most cases the chronic complications in Type 1 and Type 2 diabetes. Visit www.trinahealthmidwest.com for more information.

Press Release

Trina Health Midwest’s Patient-Driven Healthcare Aims to Disrupt Traditional Diabetes Treatment

Walk into a typical clinic and what do you see? A large waiting room filled with quiet people ignoring each other. A nurse escorts you to a small room, takes your vitals and leaves. The doctor arrives, spends a few minutes with you and leaves.

Their emphasis is on healthcare delivery, not the patient.

Compare that with the Trina Health Midwest clinic where patients are no longer bystanders. They’re active participants. The clinic fosters a relentless focus on the patient experience, creating a special place for patients to get better.

The clinic is centered around a large, communal room with eight reclining chairs, each filled with a patient wearing a Bionica Microdose Pump on their arm via an IV —the Artificial Pancreas Treatment® that slows, stops and/or, in most cases, reverses the chronic complications associated with Type 1 and Type 2 diabetes.

The Microdose pumps, about the size of a large smartphone, are extremely portable, allowing patients to wander around the room and interact with other patients and staff. Unlike the disengaged atmosphere of a typical clinic, the community oriented room is abuzz with chatter and laughter.

You might see a grandfather talking to his grandkids or a woman talking to her sister. A couple of patients may be comparing their neuropathy symptoms or discussing a recent vacation. Off to the side a CEO is on her smartphone discussing business with a client. In one chair a man is engrossed in a novel. A mother and daughter are undergoing treatment together: The mom drives four hours to be here so the two can spend the weekend together afterwards. One day seven patients brought friends and relatives to sit with them, smiling and joking, having fun together.

Artificial Pancreas Treatment

“Diabetes causes more annual deaths than breast cancer and AIDS combined,” says Mark Pound, CEO and president of Trina Health Midwest. “It has been scientifically known for a long time that the core problem of diabetes is improper carbohydrate metabolism, a result of the pancreas no longer communicating with the liver. The Artificial Pancreas Treatment reestablishes that communication.”

The heart of the treatment is the patented, FDA-approved Bionica Microdose Pump that uses an IV infusion to mimic the pulses of a healthy pancreas. It stimulates the liver to produce enzymes necessary for carbohydrate metabolism. This in turn, through DNA encoding, re-engages the cells to a healthy body, resulting in slowing, stopping, and/or reversing diabetic complications such as neuropathy, retinopathy, nephropathy, cardiovascular disease, fatigue, and erectile dysfunction among others.

Patient-driven health care

“Our purpose is to foster and grow an experience-centric patient-driven healthcare ecosystem comprised of an innovative treatment, actionable and accurate education, and a vibrant community that not only enables patients to regain their lives but also, collectively, empowers their voice to be heard,” exclaims nurse practitioner Sarah Mayer. “Our treatments are driven by each patient’s desire to improve their health rather than by a doctor ordering them to follow a specific regimen. Most of our patients have looked into other options for treating their diabetes. They want to be more involved in their own care, and that is why they come here.”

Patient health care begins with the initial visit where patients are prescreened to see if the Artificial Pancreas Treatment® is right for them. Tests determine their level of diabetic illness and whether they have conditions that prohibit treatment, such as active cancer.

“A lot of patients ask about insurance,” says clinic coordinator Joseph Lopez. “I become the patient’s advocate, making sure they get insurance reimbursement if they’re covered. If they don’t have coverage, I provide them with various options. It’s all part of our patient-driven health care.”

When the patient arrives for a three and a half to four-hour treatment, a licensed practical nurse attaches the small Bionic Microdose Pump to their arm via an IV. During the course of treatment the clinic staff has ample opportunity to get to know each patient and to provide personal care and attention. Nurses check each patient’s metabolism at the beginning, middle and end of the treatment. Patients look forward to the second and third readings to monitor how they’re doing.

When patients maintain elevated carbohydrate metabolism week after week coupled with improved symptoms, treatments are expanded from once a week to every two weeks or longer. The ultimate goal is every four weeks.

“I reassure patients they’re in a safe environment,” says Beth Conaway, a licensed practical nurse. “For example, many people are nervous about needles. I tell them we use pediatric needles designed for babies, so there’s little, if any, pain.

“If they’re new, I encourage them to join in conversations going on in the room among other patients so they feel they’re with friends. We created our environment to foster relationships and to help people find their happy.”

Each patient is constantly evaluated throughout the day. Clinic staff discusses how patients are managing their blood sugars during the week, making sure the numbers don’t get too low. They check blood pressure and recommend patients see a doctor or endocrinologist if the BP gets too low.

“I love coming to work,” Mayer says. “This is such an upbeat place. I spend all day interacting with great people—both patients and coworkers. We laugh, tell jokes and kid around.

“However, we never forget there’s serious work to be done. This is direct, one-on-one patient care. We counsel patients on nutrition. Many engage in little physical activity, so we help them take baby steps to a more active life.”

Even a simple exercise like walking is almost impossible for patients suffering from neuropathy. After a few treatments, however, it’s not uncommon for a patient to exclaim, “I can feel my feet!” This allows them to begin mild exercise, which becomes more rigorous as their condition improves.

“We’re as involved as patients want us to be,” Conaway notes. “They still need a primary care doctor. We can coordinate with their doctor and make phone or email recommendations, depending on how patients react to treatment. We encourage patients to reach out to their doctors and keep them in the loop.”

The Artificial Pancreas Treatment is not a cure

“There is no cure for diabetes at this time,” Pound asserts. “Type 1 diabetics, that undergo our treatment, must still take insulin, which will taper down over time. Type 2 diabetics often reduce the number of their meds. Part of our joy is watching patients transform into the happy, healthy individuals they were before diabetes began to grind them down.”