The FDA has cleared the Celluma, BioPhotas' biophotonic medical device, for six separate Indications-For-Use, including the treatment of acne, muscle and joint pain, muscle and joint stiffness, muscle spasm, arthritis, and compromised local blood circulation.

Research funded by NASA and DARPA using light emitting diodes (LED) or biophotonic therapy has been scientifically proven in recent clinical trials to up-regulate cellular function in the treatment of many common conditions, restoring the body's natural ability to heal itself. Contrasted to many widely accepted therapies where vital tissue is intentionally damaged to create a healing response, using LED light to "re-energize" cellular function in a non-invasive manner allows the body to maintain vitality as nature intended.

Commenting on the FDA clearance, Patrick Johnson, president and CEO for BioPhotas says, "Receiving FDA clearance for six separate indications-for-use is a major milestone for us in the development of our product portfolio and the growth of the company. Our goal in developing the Celluma was to create a safe, effective and convenient device that could be used in the home and in a professional medical setting, and to do that at a fraction of the cost of the competition. We believe we have accomplished that goal with a product that is proprietary in design and novel in clinical application for pain management and certain skin conditions."

Pain caused by a variety of reasons impacts over 100 million Americans and affects quality of life, work productivity and can be a huge emotional and financial burden. Similarly, acne is the most common skin disorder in the United States, affecting 40 to 50 million Americans. Nearly 85% of all people have acne at some point in their lives. The Celluma is designed and priced for the mass consumer market, while offering medical professionals a viable alternative treatment modality.

Continuing, Johnson says, "BioPhotas' vision is to address the rapidly growing market opportunity in global healthcare and wellness with the proven science of biophotonics and LED technology featured in the Celluma to provide effective, affordable and predictable solutions for medical practitioners and consumers alike. The Celluma will give consumers and medical professionals affordable access to a powerful clinical technology that could otherwise cost five to 20 times more, particularly when compared to cold lasers used to treat the same conditions.

The Celluma uses three distinct wave lengths of light energy, modulated with proprietary electronic algorithms to effectively treat a variety of skin, muscle and joint conditions. The Celluma is distinct from other light therapy devices given a novel flexible design that molds to the body to allow the light to be absorbed more effectively leading to higher efficacy and more predictable outcomes.

Halt Medical Inc. has received $15 million of financing to support commercialization of the Acessa System, a newly FDA cleared medical device to treat uterine fibroids.

"We are delighted that American Capital Ltd. has chosen to once again lead financing for this critical new medical device," states Jeff Cohen, Halt Medical CEO. "Furthermore, there was significant participation by existing investors, validating our work to address one of the largest unmet needs in women's health worldwide."

Acessa System is a new medical technology for treating millions of women suffering from uterine fibroids. Acessa is the only medical device that can be used by gynecologists to treat all fibroid symptoms and types. According to the Centers for Disease Control, fibroids are the leading cause for hysterectomy procedures worldwide. It's estimated that 97% of women with fibroids choose to suffer with their symptoms rather than having their uterus removed. Acessa is used in a minimally invasive same-day surgery procedure where a slender Handpiece is used to deliver radiofrequency energy to the fibroid, after which the fibroid is re-absorbed by the surrounding tissue.

In traditional fibroid surgery, layers of healthy tissue are cut through to gain access to the tumor or the uterus is removed entirely. This can lead to complications, significant pain, long recovery times and infertility. Acessa treats just the fibroids, preserving the normal function of the uterus. Patients typically go home the same day with little pain and experience rapid recovery and return to normal activities. Acessa is already being used to treat women at medical centers in Canada and Europe with outstanding results from three clinical studies.

has completed the acquisition of

(AFC), a Maryland based manufacturer of fluoropolymer bags for medical use and sterile sampling systems for pharmaceutical manufacturing processes.

AFC is considered a pioneer in the design and use of fluorinated ethylene propylene bags and has been producing innovative solutions for more than 20 years. The company's products include Vuelife culture bags, KryoSure cryopreservation bags, and KryoVue cryopreservation overwrap pouches.

"This acquisition of American Fluoroseal Corporation is complementary to the Saint-Gobain Performance Plastics film production and single use systems for biopharmaceutical manufacturing. AFC now expands our product offering into the area of vessels or bags which are used in very specific cell culture applications. Thanks to Saint-Gobain's global reach, combining the companies will allow us to partner with our global customers wherever they operate," says Michael Cahill, VP, Saint-Gobain Performance Plastics' Fluid Systems division in which the AFC business will be integrated.

Researchers with the U.S. Department of Energy (DOE)’s Lawrence Berkeley National Laboratory (Berkeley Lab) and the University of California, Berkeley, have developed an elegant and powerful new microscale actuator that can flex like a tiny beckoning finger. Based on an oxide material that expands and contracts dramatically in response to a small temperature variation, the actuators are smaller than the width of a human hair and are promising for microfluidics, drug delivery, and artificial muscles.

“We believe our microactuator is more efficient and powerful than any current microscale actuation technology, including human muscle cells,” says Berkeley Lab and UC Berkeley scientist Junqiao Wu. “What’s more, it uses this very interesting material—vanadium dioxide—and tells us more about the fundamental materials science of phase transitions.”

Wu is corresponding author of a paper appearing in Nano Letters this month that reports these findings, titled “Giant-Amplitude, High-Work Density Microactuators with Phase Transition Activated Nanolayer Bimorphs.” As often happens in science, Wu and his colleagues arrived at the microactuator idea by accident, while studying a different problem.

Vanadium dioxide is a textbook example of a strongly correlated material, meaning the behavior of each electron is inextricably tied to its neighboring electrons. The resulting exotic electronic behaviors have made vanadium dioxide an object of scientific scrutiny for decades, much of it focused on an unusual pair of phase transitions.
A single actuator curls and extends as the temperature is changed by 15°C, as shown in this micrograph. On right, a palm-like configuration of actuators all curl together, opening and closing like a tiny hand. The scale bar is 50µ.

When heated past 67°C, vanadium dioxide transforms from an insulator to a metal, accompanied by a structural phase transition that shrinks the material in one dimension while expanding in the other two. For decades, researchers have debated whether one of these phase transitions drives the other or if they are separate phenomena that coincidentally occur at the same temperature.

Wu shed light on this question in earlier work published in Physical Review Letters, in which he and his colleagues isolated the two phase transitions in single-crystal nanowires of vanadium dioxide and demonstrated that they are separable and can be driven independently. The team ran into difficulty with the experiments, however, when the nanowires broke away from their electrode contacts during the structural phase transition.

“At the transition, a 100µ long wire shrinks by about 1µ, which can easily break the contact,” says Wu, who has a dual appointment as a professor in UC Berkeley’s department of Materials Sciences and Engineering. “So we started to ask the question: this is bad, but can we make a good thing out of it? And actuation is the natural application.”

To take advantage of the shrinkage, the researchers fabricated a free-standing strip of vanadium dioxide with a chromium metal layer on top. When the strip is heated via a small electrical current or a flash of laser light, the vanadium dioxide contracts and the whole strip bends like a finger.

“The displacement of our microactuator is huge,” says Wu, “tens of microns for an actuator length on the same order of magnitude—much bigger than you can get with a piezoelectric device—and simultaneously with very large force. I am very optimistic that this technology will become competitive to piezoelectric technology, and may even replace it.”

Piezoelectric actuators are the industry-standard for mechanical actuation on micro scales, but they’re complicated to grow, need large voltages for small displacements, and typically involve toxic materials such as lead. “But our device is very simple, the material is non-toxic, and the displacement is much bigger at a much lower driving voltage,” says Wu. “You can see it move with an optical microscope! And it works equally well in water, making it suitable for biological and microfluidic applications.”

The researchers envision using the microactuators as tiny pumps for drug delivery or as mechanical muscles in micro-scale robots. In those applications, the actuator’s exceptionally high work density—the power it can deliver per unit volume—offers a great advantage.  Ounce for ounce, the vanadium-dioxide actuators deliver a force three orders of magnitude greater than human muscle. Wu and his colleagues are already partnering with the Berkeley Sensing and Actuation Center to integrate their actuators into devices for applications such as radiation-detection robots for hazardous environments.

The team’s next goal is to create a torsion actuator, which is a much more challenging prospect. Wu explains: “Torsion actuators typically involve a complicated design of gears, shafts and/or belts, and so miniaturization is a challenge. But here we see that with just a layer of thin-film we could also make a very simple torsional actuator.”