“Breaking Through the FDA” (Biosphere, 2021)

Innovative medical devices and diagnostics can get to patients and providers sooner under the U.S. Food and Drug Administration’s (FDA) Breakthrough Device Program. The program provides a special regulatory Breakthrough Device Designation for medical products that have the potential to more effectively treat or diagnose serious or life-threatening conditions. See the full article on page 19 >

Answering some common questions about PhotoPharmics

As a medical device company on the edge of a major breakthrough, we get a lot of questions from people who are curious about our work and mission. We love that so many are interested in our work! We truly believe we have the technology and experience to change the world.

To make things easy for those who would like to know more about PhotoPharmics, we decided to publish a list of some of the most common questions we get, along with our answers. Enjoy!

Q: What is PhotoPharmics?

A: PhotoPharmics is a clinical-stage medical device company which has developed a specialized phototherapy device to treat neurodegenerative diseases. We are the first company with a specialized, home-use phototherapy device for people with Parkinson’s disease to receive significant recognition by the FDA as a Breakthrough Device. Our device is slated to enter a phase 3 clinical trial. We are leading the way on what could be the biggest breakthrough in Parkinson’s disease treatment in decades!

Q: What experience does the PhotoPharmics team have?

A: Our founders have more than 30 years of experience in the field of phototherapy, having previously developed specialized light solutions that are now widely used to regulate circadian rhythms in treating seasonal affective disorder (“winter blues”), sleep disorders, anxiety and depression.

Q: What is PhotoPharmics’s connection to Parkinson’s disease?

A: When it comes to Parkinson’s disease, we feel two major calls to action: First, we are using our vast experience to pioneer technology that could potentially be the biggest breakthrough in PD treatment in decades. Second, we feel a great need to raise awareness of the devastating non-motor symptoms of Parkinson’s disease which, unfortunately, rarely get discussed but can be even more life-altering than the motor symptoms.

Q: What does your device do?

A: Our specialized phototherapy device was designed to address and improve the motor and non-motor symptoms of Parkinson’s disease by stimulating regulation of the body’s natural circadian rhythm.

Q: Does it work?

A: Yes. Our phototherapy technology has been shown in clinical trials to improve the serious non-motor symptoms of PD as well as overall quality of life on top of best managed care.

Q: How does your device work?

A: Our home-use, non-invasive light therapy device uses a specialized, proprietary combination of light intensities and bandwidths to target the photoreceptors in the eye, creating a therapeutic effect to ease disease symptoms.

Q: Is your device part of any upcoming clinical trials?

A: Yes. PhotoPharmics has partnered with the Center for Health and Technology at the University of Rochester to begin a phase 3 clinical trial. It will be an at-home trial with 200 participants over six months. Participants will submit their information remotely utilizing technological innovations, opening the trial to some who would otherwise be inaccessible.

Q: Can you safely conduct a clinical trial under the conditions of a global pandemic?

A: Yes! Our trial will be conducted remotely. Each Participant will receive a device, and they will perform every function of the trial at home, including doctor visits and submitting personal results via the internet. It is a safe, non-invasive, stay-at-home trial, perfect for our time.

Q: Does the device interfere with daily life?

A: No. Research participants found the device (about the size of a laptop computer screen), to be safe and convenient to use while watching TV, reading, using a smartphone or taking part in other seated activities.

Q: Where can I learn more?

A: Sign up to be notified as more details emerge about PhotoPharmics, our specialized phototherapy device and upcoming trial information: PhotoPharmics.com/connect

The importance of good diet and nutrition for people with Parkinson’s

Remember when your mom used to tell you to eat your vegetables? What a smart lady! It turns out (shocker) that eating a diet of nutrition-rich foods like fruits and vegetables is good for your health.

Thanks mom!

Now that’s true for everyone, of course, but since we’re a company that focuses on the treatment of neurodegenerative diseases like Parkinson’s, we wanted to take a closer look at the effects of good nutrition on people with Parkinson’s disease. And thankfully for us there was a lot of great information out there. The effects of a good diet on Parkinson’s disease is a subject that has been covered extensively by researchers, scientists and advocacy groups.

We collected some of our favorite articles, and we also asked people with Parkinson’s and their caregivers to weigh in on the subject.

“My mom with Parkinson’s seems more positive and motivated when she feels good from eating well,” said Brenda Carpenter, who is one of her mother’s primary caregivers.

Diana Gainer, who cares for her husband with Parkinson’s, said a good diet—even though it can be challenging to manage—helps a whole lot. “Eating a balanced diet is good for general health, so it’s definitely [good] for people with Parkinson’s.”

But what exactly do we mean when we say “good” diet and nutrition? After all, there are LOTS of different opinions out there when it comes to nutrition.

We like this summary from the Michael J. Fox Foundation: “a balanced diet full of fruits and vegetables promotes health and well-being for everyone.”

The summary continues, “one part of a healthy diet is eating foods with antioxidants. These ‘good for you’ molecules help protect cells from stresses such as air pollution, cigarette smoke and even the process of converting food to energy. Antioxidants are found in fruits, vegetables, grains, nuts, dark chocolate and some beverages, such as red wine, coffee and tea.”

Eating these sorts of good foods can help ease many symptoms of Parkinson’s disease, both motor and non-motor. Here are some specific symptoms that could be managed with good diet and nutrition:

Constipation: Fruits, vegetables, beans and whole grains are high in fiber, which help regulate the digestive system and keep things moving.

Dehydration: People with Parkinson’s tend to be dehydrated more than most (sometimes due to medication). Dehydration can lead to issues with balance, confusion, weakness and even kidney problems. Drinking lots of water and eating a plant-based diet will ensure the body is properly hydrated.

Inflammation: Another common symptom of Parkinson’s disease is excessive inflammation, leading to pain and other kinds of discomfort. Fresh fruits and vegetables, whole grains and lean proteins are known to be anti-inflammatory.

“While there is no prescription for a PD-specific diet,” says the Parkinson’s Foundation, “to maintain overall good health most people living with Parkinson’s disease should eat a variety of whole grains, vegetables, fruits, milk and dairy products, and protein-rich foods such as meat and beans. Also consider including nuts, olive oil, fish and eggs to your diet, for their beneficial fats.”

Interested in learning more about the effects of good diet and nutrition on Parkinson’s disease? Here are some more resources:

Diet & Nutrition – The Michael J. Fox Foundation
Fighting Parkinson’s Disease with Exercise and Diet – Johns Hopkins Medicine
The Best Diet for Parkinson’s Disease – The Cleveland Clinic
Parkinson’s Disease – Food for the Brain Foundation
Eating with Parkinson’s – Parkinson’s Association of San Diego
Diet & Nutrition – Parkinson’s Foundation

And to learn more about how PhotoPharmics is using light therapy to treat the motor and non-motor symptoms of Parkinson’s disease, be sure to sign up for our email list at PhotoPharmics.com/Connect.

The benefits of being outside for people with Parkinson’s

We absolutely love Spring. There’s something so magical about the awakening power of Spring after a long and cold winter. One of the things we love most about this time of year is that it allows us to start getting outside again into the warm and sunny weather.

And since we’re always thinking about Parkinson’s disease, and the millions of courageous people around the world who battle its motor and non-motor symptoms every day, we got curious: Does being outside have a particular benefit for people with Parkinson’s?

We did some research, and what we found was fascinating! Here’s what some leading minds in Parkinson’s disease research had to say about the subject.

The Brian Grant Foundation, a Parkinson’s awareness organization created by the former NBA star after his diagnosis in 2008, says being outdoors has tremendous health benefits for people with Parkinson’s.

The site suggests people with Parkinson’s, well, take a hike.

“Depending on the length and intensity of the trail, and the steepness of your incline, you’re in for a powerful cardio workout that can lower your risk of heart disease and improve your blood pressure and blood sugar levels, while filling your lungs with fresh, clean air.”

In addition to being a great workout, the article notes, hiking outdoors can be a soothing way to clear your mind while enjoying nature.

“Adding to the fact that you’re taking in the mesmerizing sounds of wildlife and some of the most scenic views Mother Earth has to offer—be it forests, mountains, deserts, waterfalls, rivers or creeks—hiking nourishes the mind, body and soul in ways no other workout can.”

Spending time outdoors is more than just good advice, however. Scientific studies have shown experiences in nature can help relieve certain symptoms—non-motor and motor alike—among people with Parkinson’s.

The National Institutes of Health (NIH) recently published some research indicating walking on the uneven surfaces of the great outdoors could help people with Parkinson’s relieve the freezing-of-gait symptom, in which they feel like their feet are stuck or glued to the ground.

The study’s abstract concludes, “our results, if repeated in future studies, may have significance to everyday lives of PD patients, who could get a simpler life by consciously prioritizing stays in natural surroundings.”

Read the entire study here.

The Michael J. Fox foundation, an always reliable source for the latest Parkinson’s disease research and discussion, also had great things to say about being in the outdoors.

In this article, the MJFF explores a study reporting that nature walks are good for our brains.

And here they suggest seven Spring workouts for people with Parkinson’s symptoms.

Finally, we took it straight to the people themselves. We asked some of the biggest Parkinson’s communities on social media to weigh in on the subject, and the answer was clear: Being outdoors makes a big difference.

“For some reason I can walk through the park on trails better than in my house,” Mike F. said. “I do still ‘freeze,’ but not as often or severe! Exercise definitely helps!”

“Gardening really helps me,” Shaun M. said.

Shawn H. added, “the Vitamin D from sunshine and fresh air help alot [sic].”

“My [husband with Parkinson’s] just appreciated getting out and seeing the world because in the last year and a half of his life it happened so little,” said Hillary M., a Parkinson’s caregiver. “Cheered him right up to see trees and flowers, or even the neighbors’ front lawns – I’d take him down the stair lift, out the door, and set him up on a chair on our front steps.”

“Just being outside is a gift,” Mark B. said.

Don’t let this good weather go to waste! Do something good for your body, mind and soul, and spend some quality time outside.

Survey highlights eagerness for Parkinson’s disease breakthrough discoveries

We at PhotoPharmics are passionate about representing the Parkinson’s community in an effort to raise awareness. In a recent survey, PhotoPharmics discovered a large percentage of people are waiting with great eagerness for breakthroughs that will improve the standard of care for people with Parkinson’s.

“We have made a strong effort to become a trusted contributing voice in the Parkinson’s community, and what we’ve found through our informal research is that this is a group that is ready and waiting with great anticipation to see a significant step forward in terms of Parkinson’s disease care,” said Brett Walker, spokesperson for PhotoPharmics.

The survey was shared through the biggest online Parkinson’s disease groups, and collected 108 responses. 66 (or 61%) said they did not expect to see a breakthrough in Parkinson’s disease treatment in their lifetimes, and 42 (39%) said they did.

Walker believes the results of the survey tell two, yet equally positive, stories.

“On the one hand, we believe it’s significant that nearly 40% of respondents are optimistic about breakthroughs coming in their lifetimes,” he said. “And in the other 60% we see a group with some significant unmet needs who is actively engaged, and waiting with eagerness for a major advancement.”

Leading Parkinson’s disease advocacy and research groups like the Michael J. Fox Foundation are followed closely by the Parkinson’s disease community. They regularly publish new Parkinson’s disease findings on their Websites and social media channels. Likewise, groups like the Parkinson’s Foundation, and the International Movement Disorders Society fund and publish important research relating to Parkinson’s disease.

“There are incredible organizations who have made Parkinson’s research their missions. They publish new information almost daily, and that information drives innovation from companies like ours,” Walker said.

The ongoing research surrounding phototherapy, or light therapy, as a treatment for Parkinson’s disease is of particular interest to PhotoPharmics. With a staff that boasts over 30 years’ experience in the field of light therapy, PhotoPharmics is on the vanguard of Parkinson’s disease treatment breakthroughs. Their proprietary technologies and research have been widely used and acquired by major players in the medical field to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression.

“We aim to make a clinically meaningful difference in patients’ lives by delivering safe and effective treatments,” said Kent Savage, PhotoPharmics CEO. “We are currently extending our research into other neurodegenerative diseases, and Parkinson’s disease specifically.”

PhotoPharmics is currently preparing for a phase-three clinical trial for a medical device they’ve developed specifically to address the non-motor and motor symptoms of Parkinson’s disease. This device recently received Breakthrough Device Designation by the United States Food and Drug Administration (FDA).

According to the FDA’s Website, “the Breakthrough Devices Program is a voluntary program for certain medial devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment, and review.”

“Very few device companies receive Breakthrough designation,” Savage said. “Our device is the first specialized phototherapy device to achieve this status.”

“We hope to someday soon offer the major breakthrough so many are looking for,” Walker added. “We’re working on it every day.”

Those interested in learning more about PhotoPharmics, its upcoming clinical trial or its connection to the Parkinson’s community are invited to connect with us at PhotoPharmics.com/connect.

Living with a Parkinson’s diagnosis? People with PD offer advice, words of encouragement

One question sparks hundreds of thoughtful, compassionate responses

AMERICAN FORK, Utah—More than a million people every year are living with Parkinson’s disease in the United States. Over 60,000 are diagnosed every year, and many more are suffering without a formal diagnosis. It’s likely your life or the life of someone you love has been affected by Parkinson’s disease in one way or another.

But life is bigger than one disease, and nobody knows that better than the Parkinson’s community—a network that includes people with Parkinson’s, caregivers, family, friends and other supporters.

Recently this group banded together in big numbers to offer support and encouragement to newly diagnosed people with Parkinson’s. Over 530 people shared their answer to a simple question posed on some of the largest PD communities on Facebook: “What advice or encouragement would you give someone who has just been diagnosed with Parkinson’s disease?” The overwhelming feedback demonstrates the compassion and care of a community bound together by a devastating neurological disease.

“Learn exactly how patient you can be, and then learn to double it. At least,” said one Facebook user.
“Seek out positive role models, like [Michael J.] Fox,” said another. “Listen to his books, participate in research so you can feel empowered.”

Opinions and experiences were varied, since the question was posed to the entirety of the Parkinson’s community. Some of it was practical, such as the advice to get an attorney, or seek out the best care possible. Some of the advice was more philosophical, like the advice to “live life to its fullest,” or “enjoy every moment of every day.”

The common thread, however, was the desire to help. The answers came back quickly, and everyone who responded was eager to offer assistance, demonstrating the caring, nurturing, and optimistic nature of this unique community.

“We have learned so much about the Parkinson’s community over the years,” said Brett Walker, PhotoPharmics spokesperson. “One of the best things we’ve learned is the extent to which they support each other and rally around each other. When someone joins this community, they are immediately received into a network of love and support. When someone asks a question or seeks advice, the people respond in a big way.”

The responses were deeply heartfelt and often moving, and show the raw perspective of what it’s like to be ingrained in Parkinson’s disease.

Here are a few more bits of advice from the Parkinson’s community:

“Don’t let PD dictate your life. There will be plenty of time for that later.”

“I say to you, know you have more to offer than PD. Know deep inside there is an energy that ignites your deepest motivations. And stand willingly, no matter how shaky, and be determined to show others that we can’t be placed in a box.”

“Don’t listen to scary stories of what could happen. Everyone has different symptoms and reacts differently to various medications. The updated treatments available now are very good.”

“I would suggest that you find a neurologist that specializes in movement disorders & start physical therapy to remain active. I was lucky to find a PT who specializes in movement disorders & brain injuries. A good PT will give you exercises that you can do at home.”

“Here is what works for me. Exercise, eat healthy, practice yoga, eliminate negative situations and strive for a low stress lifestyle. Get busy living and moving while you can because nobody knows what’s around the next bend. Be kind to yourself and ask for help when you need it.”

“Go on a nice trip.”

“You are not your diagnosis. Stay true to you and stay active. Find a support group for difficult days and know that you are loved and supported by friends and family no matter how bad the day feels.”

“Tell family and friends so they understand.”

“It’s not a death sentence. You’ll just need to make a few adjustments to your daily routine.”

For more research and news from people with Parkinson’s, as well as updates on what PhotoPharmics is doing to introduce breakthrough Parkinson’s treatment technology to the world, follow PhotoPharmics on Facebook, Twitter and Instagram, and sign up for PhotoPharmics updates at PhotoPharmics.com/connect.

About PhotoPharmics

PhotoPharmics is a privately held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative diseases. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms in seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective non-invasive treatments. Investor inquiries are welcomed. Learn more at www.photopharmics.com.