As promised, we’re back with more about Regenerative Medicine. Our first profile is on Organogenesis, a company based in Canton, Massachusetts, who is at the forefront of the field. Their website states that “in the future, regenerative medicine technologies may deliver neural regeneration, islet cells for diabetes, and more substantial heart repair.” For Organogenesis, this process starts with healing chronic wounds.
Organogenesis has a product on the market called the Apligraf. The Apligraf mimics human skin to kick-start the healing process. Imagine living for years with an open wound—if you last this long without having to lose your limb that is. Organogenesis’ Apligraf can save the lives of people doing just that, it can save limbs and lives with the simple regeneration of skin cells. The new skin-like graft is created from donated foreskin from circumcision. That may sound weird, but since the Apligraf was developed it has taken twelve donated foreskins and made enough cell lines to create half a million Apligrafs. They take the foreskin cells, break them down, and then fibroblasts and keratinocytes, a bottom and top layer respectively, are used to create a remarkably skin-like bilayer graft.
This forty-four square centimeter cell culture can be applied to diabetic foot ulcers as well as venous leg ulcers, which makes it unique from any other similar product. It is designed to be applied to the patient’s wound and using the young and healthy cells in the Apligraf stimulate the body to make cells and heal itself. This revolutionizes the healing process for people with chronic wounds and can give them their lives back!
Want to know more about what else Organogenesis is doing? Stay tuned until our next post when we talk about the rest of their technology! Let us know what you think so far at @TRA360!
In the TRA360 Regulatory Writing practice, we are always on the lookout for companies that can add value in this space. Bibra Toxicology Advice and Consulting is one such company. They are a small company based in the UK. Bibra provides advice for toxicology during the process of clinical trials.
Bibra’s team of 15 toxicologists has a combined total of over 250 person years of experience in this field. All of their consultants are experts in the field of toxicology. They have completed many engagements for different customers across a broad range of disciplines. What about governmental compliance work? Bibra has a relationship with many governmental regulatory agencies, in the UK and internationally. Recently, their team worked with an unnamed international industrial chemicals manufacturer on compliance work. They worked with them to adhere to the United States Toxic Substances Control Act (TCSA) in collaboration with the Natural Resources Defense Council (NRDC). This compliance work can be found in the Recent Projects section of their website. Their team always meets their deadlines, an essential for success in clinical trials.
If you need toxicology advice for your business be sure to check out Bibra! Let us know how everything turns out @TRA360!
Biosoftworld Medical develops products specifically targeted to technology-savvy medical professionals. The company writes software that performs electronic scheduling, billing, and record keeping tasks. Their products enable today’s doctors to keep more accurate and readily accessible patient files. Biosoftworld Medical has seven products in its portfolio. This blog post describes two of them.
The first, Medical Scheduler, allows doctors to keep the most accurate filings on a patient’s history. It includes a way to take templates created by the user and write full reports using the information specific to the practice. Need to translate your report? No problem, Medical Scheduler comes fully equipped with translational capabilities. What about your current calendar? No need to worry, the calendar within Medical Scheduler supports Apple iCal, Lotus® Notes, Google Calendar, Novell GroupWise®, and Windows Calendar making it even easier to sync and export your calendar to other places. Need to attach files to a patient? Easily done with Medical Scheduler as you can attach nearly every file type to enrich a patient file with pictures, additional records, or anything else you would need. You can access medical records, billing records, and schedules for all doctors within the practice directly from Medical Scheduler. Statements and bills are easily printed off the program without exporting to another source! What about appointment changes? No sweat, appointments can be easily dragged and dropped between time slots and doctors. Care about the ease of your patients? Medical Scheduler allows you to create a waiting list for your patients so they know exactly where they are while in the waiting room. You can also set reminder calls and emails to be made and sent directly through the program for your patients.
Biosoftworld also has comprehensive billing software. Their Medical Office One Family enables you to connect a family in order to bill them all at once. It is HIPPA-compliant, and integrates with QuickBooks. You can access unlimited databases for unlimited providers to bill. Also, the forms are easily printed with the program. But what if you need to send the claims electronically? It’s very easy with Medical Office One Family; clearinghouses can receive the claims sent directly from the program.
Are you a doctor or other medical professional? Check out the software provided by Biosoftworld Medical and let us know @TRA360 what you think!
We’re back with more on Organogenesis. We figure if Organogenesis doesn’t stop at one life changing product, why should we stop at one blog about them. Welcome back and enjoy the rest of what they have to offer.
Organogenesis also developed an oral soft tissue to replace the process of palatal grafting. For people with receding gums, the normal fix involves taking pieces of the palate and grafting them into the gum to replace the tissue. The process is just as painful as it sounds, you get two wounds for the price of one graft. Plus it usually involves multiple surgical procedures since the palate is so small. In response, Organogenesis introduced the Gintuit. The Gintuit is made of isolated living cells from human skin and grown with bovine collagen. This enables the doctor to have enough tissue to replace a large section of gum without having to cut the palate and keeps the patient from enduring multiple long and painful procedures.
In addition to these products, Organogenesis developed technology for the transportation of their products. In order to ensure the best results they, like Wendy’s, ensure their Apligrafand Gintuit are “fresh never frozen.” Organogenesis gets their products around the world by the next day while maintaining the body’s natural temperature for optimum cell life. Even better than that, when kept at body temperature the shelf life of these products is an amazing ten days. Other like products are shipped frozen and doctors are alerted that through the process of freezing and thawing cells, some are lost. With the Apligraf and the Gintuit, freezing and thawing are not an issue so more cells remain intact for optimum results on the patient.
With two life changing products and a revolutionary way of storing the products, Organogenesis provides a new face for regenerative medicine. Providing relief to those with chronic wounds, and giving those who need a gum graft with a less painful and invasive option, Organogenesis is giving people their lives back, and providing them with the relief they have been searching for.
Check in with us again as we continue this series with other companies like Organogenesis. Know someone who would like to be featured? Have any comments on this article? Let us know here or tweet at us @TRA360!