Based in Dallas, TX, Qualia, Inc. was founded in 2015 to translate neuro- and biotechnologies to novel research tools and human clinical therapeutics through its host of subsidiaries and affiliates.
The company’s near-term goal focuses on fostering the expansion of neural electronics research through the design and development of a range of softening neural research tools. These devices enable academic and corporate researchers to chronically interface with target nerves in animals to map neural circuits, regulate biological processes, and ultimately treat a range of clinical conditions by stimulating, recording, or blocking key neural signals in the body. Devices are implanted while stiff to enable better surgical handling over softer devices. However, after implantation, they soften by 2-3 orders of magnitude to minimize scarring that can occur with stiffer silicon-based devices.
Longer term, Qualia aims to develop additional novel bio, electronic, and materials technologies including gene editing, microneedle arrays, drug encapsulation, robotics, and wireless technologies for incorporation into additional research tools as well as to enable multi-prong approaches and combination products for the treatment and prevention of specific clinical disorders ranging from chronic back pain to multiple sclerosis to acute radiation syndrome.
Research related to the innovative technologies of Qualia, Inc. reaches back over a decade. Since the founding of the company in 2015, we have grown our team incorporating MDs, PhDs, MS, and MBAs. Qualia, Inc. has a core leadership team assisted by medical and academic advisors throughout the country.
The combination of world-class research, market drive, and a passion for improving the medical field through biotechnology has resulted in a half-dozen subsidiaries and affiliates since our founding in 2015. Each company, with its own leadership and clinical advisors, focuses on a unique challenge within the medical world.
Regulife Medical is a modern biomedical device company applying proprietary, neuromodulation technology to clinically-approved, implantable predicate devices which interact with the enteric nervous system to soothe gastrointestinal discomfort, improve real-time clinical diagnostics, and enhance patients’ quality of life.
Our mission is to:
Help patients monitor and respond to daily life
Arm clinicians with proactive real-time diagnostics of patient GI systems
Advance treatment of inflammatory bowel diseases like Crohn’s Disease and ulcerative colitis
Provide relief for irritable bowel syndrome, constipation, and small bowel dysmotility
Regulate metabolic activity (diabetes, obesity, fatty liver)
As a biomedical device company passionate about improving the lives of individuals through better hearing technology, Qualia Oto utilizes our core innovations to produce top-quality, shape-changing polymers and matrix-addressed electrode arrays embedded in devices for our customers' medical and personal needs.
Our softening, shape memory polymer components and thin-film arrays used within cochlear implants can provide increased effectiveness and stimulatory resolution for chronic, targeted micro-stimulation
Our drug-eluting polymer microneedle arrays for inner-ear drug delivery can combat diseases affecting hearing and balance, such as Ménière’s disease
Inspire Bioelectronics is working to strengthen application-specific IP portfolio and prioritize data-driven market penetration with COVID-19 patients during this current national pandemic.
Inspire fabricates auricular neurostimulators with an AI + materials solution for enhanced multi-channel neuromodulation. These neural interface devices photolithographically pattern metal electrodes on softening polymer substrates as thin as tens of microns. Electrical stimulation of the auricular vagus nerve has disease mitigating effects and therapeutic applications, such as chronic pain diseases, neurodegenerative and metabolic ailments, and inflammatory and cardiovascular diseases.
Advantages of this neuromodulation include: targeted stimulation helping to avoid systemic side-effects associated with drug therapies; well-tolerated neurostimulation with few dangerous side-effects; and a treatment that can be stopped at any time.
Qualia Labs serves the non-clinical neuroscience research community by developing methods that enable the use of standard electronics microfabrication processes to manufacture neural interface devices – including cuffs, blankets, spinal cord devices, intrafascicular probes, brain probes, and epicortical arrays – on shape memory polymers.
The SMP substrates can withstand solvents and high temperatures involved in photolithography processing thus allowing us to take advantage of the high-quality repeatability of these processes. The SMP also gives the device the necessary mechanical stiffness for surgical handling. Once implanted, the substrate softens by two orders of magnitude to reduce tissue strain, resulting in improved tissue response and device performance over longer periods of time.
Additionally, piloting new novel devices with researchers will empower the academic community with greater tools and will also provide necessary feedback to reduce risks in commercializing human clinical therapeutics.
Backstop Neural constructs softening spinal cord stimulators – core innovative technology which is based on DARPA and NIH-funded research in shape memory polymer (SMP)-based neural bioelectronics. These stimulators are designed to reduce inflammation and device migration:
Leads can be fabricated as thin as tens of microns using photolithographic microfabrication processes
Leads are implanted while stiff and rigid to enable surgical handling and device robustness
After surgery, the lead substrate softens by one to two orders of magnitude and conforms to the spinal cord to reduce hardware-related complications including lead migration and breakage, as well as mitigating physiological reactions such as foreign body response and inflammation
Capavax seeks to overcome the need to receive multiple vaccinations over the course of months or years by encapsulating vaccines into slow release formulations. Our solution would directly meet the needs this technological void by developing a biocompatible mixed-matrix composite that integrates biological therapeutics into biodegradable plastic resins, which can be processed into microneedle arrays. Conceptually, a vaccine would be immobilized into material for delivery, which would then be injected into the patient allowing the material to dissolve permitting slow release. An emerging method for this type of vaccine delivery has been drug coated or loaded microneedles for transcutaneous delivery.
The idea of microneedle vaccine delivery is to impregnate or coat a planar sheet with exposed micron-sized projections with a therapeutic and then press the sheet into the skin. These needles are long enough to penetrate the outer layer of dead skin— the stratum corneum—to deliver drugs to the vascular and living dermis where they are distributed systemically.
PREACT Medical aims to create rapidly-deployable, transient, generalizable, and safe gene expression modulators to protect warfighters, first responders, and civilians against acute radiation syndrome (ARS) and opioid toxicity.
Current medical countermeasures (MCMs) to these national security threats – including granulocyte colony-stimulating factor (G-CSF) for radiation exposure and naloxone for opioid overdose – suffer from the need for rapid post-exposure administration, short half-lives in vivo, and lack of generalizability among other drawbacks. Recent advances in gene expression-modifying technologies, including epigenetic activators and repressors, selective alterations of RNA expression, and RNA base editing, have the potential to alter the clinical paradigm for these threats by temporarily bolstering endogenous host defense mechanisms either before or immediately after threat exposure.
The PREACT team has combined our expertise in synthetic biology, bioinformatics, radiation chemistry and biology, pain biology, and clinical translation of RNA-modifying therapeutics. Our cross-discipline expertise enables unique opportunities to expand our knowledge of these disease states and PGM technologies while focusing squarely on a clear, ambitious, and safe path towards a novel class of transient therapeutics.
Skin Aware’s goal is to improve skin-based allergy testing with a miniaturized flexible bioelectronic device. This device seeks to detect allergic reactions, minimize patient discomfort, reduce the allergen used, and represent a new paradigm; it also provides four orders of magnitude modulus softening capabilities, originating from cortical implants research, and is 2µm feature size.
The microneedles used in this process are peptide-based polymers that dissolve after delivery, and they establish a relationship with CMU collaborators while minimizing dosages and maintaining delivery control. Moreover, our temperature sensors have a 1/10th °C precision, as well as flexibility to radii below 700µm, and they are connected to visual readout.
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