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[hope67] 31/3/2020 19:13

BACKGROUND OF THE INVENTION
The supply of therapeutic oxygen to patients in homes and other residential settings is an important and growing segment of the health care industry. Oxygen can be supplied to a patient by liquid or compressed oxygen with an appropriate vaporization or pressure regulation system and a gas delivery cannula. Alternatively, oxygen can be supplied by the generation of oxygen using a small onsite air separation device or medical oxygen concentrator located near the patient that delivers the generated oxygen via a cannula.

Respiratory oxygen usage rates typically range up to 3 LPM (liters per minute at 22° C. and 1 atmosphere pressure) for ambulatory patients with relatively low oxygen requirements, up to 5 LPM for patients with more serious respiratory problems and possibly limited mobility, and in certain cases up to 10 LPM for those with the most serious respiratory problems and more limited mobility. A patient initially may require a higher oxygen supply rate during an illness and later may require less oxygen as recovery is achieved. Alternatively, a patient may require increasing oxygen rates as a chronic condition worsens. A conserver may be used to provide oxygen flow only when the patient inhales, thereby reducing the amount of oxygen required by eliminating the supply of oxygen that is wasted when the patient exhales.

Portable medical oxygen concentrators often are preferred over liquid or compressed oxygen supply systems in home and residential settings, and small air separation devices for these applications are being developed by numerous vendors in the home health care field. Patients typically are encouraged to be ambulatory whenever possible to increase the effectiveness of oxygen therapy and improve their overall health. The portability of a medical oxygen concentrator therefore is an important feature allowing the patient to move about easily and comfortably. To maximize portability and ease of use, the medical oxygen concentrator must be designed to have minimum weight and compact dimensions. Patient ambulation time can be maximized by the use of a conserver.

There is a need in the home health care field for an improved, lightweight, battery-powered portable oxygen concentrator for delivering oxygen product to ambulatory patients. These patients typically require a concentrator that can generate up to about 3 LPM of oxygen on a continuous basis and that includes a built-in conserver that maximizes ambulation time. The invention is directed to these, as well as other, important ends.

[the patient investor] 31/3/2020 19:09

Hope

Try this

[hope67] 31/3/2020 18:39

I would think after all this time they would hope to get full FDA approval. We know they are already in talks with the manufacturers just need that final approval now get Edale out and then the brakes come off.

[hope67] 31/3/2020 18:36

the patient investor have you got a link to that person would be very interested was it posted somewhere?

[hope67] 31/3/2020 18:33

rishisunak
@RishiSunak
·
31m
I'm waiving import taxes on vital medical equipment including ventilators, coronavirus testing kits and protective clothing.

Dealing with #coronavirus is a collective national effort and I will do everything I can to help us win this battle.

[the patient investor] 31/3/2020 17:05

rumours of an imminent FDA approval following this week's inspection


the guy who suggested this was 100% correct in predicting NCYT fda approval, he got it right by the hour

not sure if still applies to this

[superg1] 31/3/2020 16:59

Back end of last summer a few of us discussing it long before the Covid crew arrived.

One post risked was food re Soda lo v Salarius and that was the hollow spheres which break down dissolve in the snacks environment.

Talk is good

As I recall glasses general thought be all to be a stupid idea.

Bellluscura for COPD best of the bunch by a long way.

Last few weeks new posters re Coronavirus

[superg1] 31/3/2020 16:46

It's called debate, try a few 100 posts ago before the herd arrived due to the virus

[superg1] 31/3/2020 16:00

Could be just like you say.

[hope67] 31/3/2020 14:53

The Oxygen concentrator is Class II only needs 510k application. And the Fda have brought in new rules.

[hope67] 31/3/2020 14:50

Products in the Pipeline:

The technology Belluscura is developing and licensing is allowing the company to develop oxygen concentrators that are anticipated to be significantly smaller, lighter, quieter, more energy efficient, and less expensive than units and systems currently available on the market. Moreover, these attributes along with additional innovations allow us to create an oxygen platform technology beyond the prescription portable oxygen market to include smaller stationary units than currently available, recreational and industrial units, wound care units, drug delivery units and even a next generation portable artificial lung.

Belluscura’s current pipeline oxygen concentrators are considered Class II prescription products that must receive Food and Drug Administration (FDA) clearance through what is known as a 510(k) application. The purpose of a 510(k) submission is to demonstrate that a device is “substantially equivalent” in safety and efficacy to a predicate device (one that has been cleared by the FDA or marketed before 1976). The 510(k) applicant compares the subject and predicate devices, explaining why any differences between them should be acceptable to the FDA. Human data is not required for an oxygen concentrator 510(k) submission.

By comparison, a Premarket Approval (PMA) is used to demonstrate to the FDA that a new or modified device is safe and effective. This standard is higher than is required for 510(k) submissions. Much like a new drug, human use data from a formal clinical study is almost always required in addition to laboratory studies. Belluscura anticipates that its artificial lung technology could be subject to PMA requirements.

[mcrudden] 31/3/2020 14:50

You are correct and I'm sitting waiting for this to be approved. Part of the paperwork has been completed as far as the usability study, so it could be any day now. It's a great product and potential upside is superb

[hope67] 31/3/2020 14:48

hxxps://www.portableoxygen.co.uk/phillips-respironics-simplygo-mini/

www.portableoxygen.co.uk (hxxps://www.portableoxygen.co.uk/phillips-respironics-simplygo-mini/)

Maybe Philips will be interested in a lighter version.

[hope67] 31/3/2020 14:47

Superg1 isn't the Pma for the artificle lung they are developing?

[superg1] 31/3/2020 14:01

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices.

The current submission is the lower level 510k

When it reviewed they will either get the thumbs up or no you need do a PMA.


It's better imo to be aware of these things rather than moan and scream about it if it happens.

So all nailed on unless they say PMA approval required

[superg1] 31/3/2020 13:58

TPI

Read the Belluscura site

they have submitted the 510k application but say it may be determined that it needs to be a PMA submission which is higher grade, until they get result we won't know.

By comparison, a Premarket Approval (PMA) is used to demonstrate to the FDA that a new or modified device is safe and effective. This standard is higher than is required for 510(k) submissions.

Belluscura anticipates that its artificial lung technology could be subject to PMA requirements.


It's a shame Tek forgot to mention that in their news. If it needs a PMA version then there will be no approval, a new process will start.

[the patient investor] 31/3/2020 12:16

No delay
Read the info
90 days from february rns

[superg1] 31/3/2020 11:29

Supertag

So the FDA delay could be down to it needing the PMA and a new submission for the higher standard PMA submission.

Time will tell.

[superg1] 31/3/2020 10:32

Products in the Pipeline:
The technology Belluscura is developing and licensing is allowing the company to develop oxygen concentrators that are anticipated to be significantly smaller, lighter, quieter, more energy efficient, and less expensive than units and systems currently available on the market. Moreover, these attributes along with additional innovations allow us to create an oxygen platform technology beyond the prescription portable oxygen market to include smaller stationary units than currently available, recreational and industrial units, wound care units, drug delivery units and even a next generation portable artificial lung.

Belluscura’s current pipeline oxygen concentrators are considered Class II prescription products that must receive Food and Drug Administration (FDA) clearance through what is known as a 510(k) application. The purpose of a 510(k) submission is to demonstrate that a device is “substantially equivalent” in safety and efficacy to a predicate device (one that has been cleared by the FDA or marketed before 1976). The 510(k) applicant compares the subject and predicate devices, explaining why any differences between them should be acceptable to the FDA. Human data is not required for an oxygen concentrator 510(k) submission.

By comparison, a Premarket Approval (PMA) is used to demonstrate to the FDA that a new or modified device is safe and effective. This standard is higher than is required for 510(k) submissions. Much like a new drug, human use data from a formal clinical study is almost always required in addition to laboratory studies. Belluscura anticipates that its artificial lung technology could be subject to PMA requirements.

[superg1] 31/3/2020 10:29

Hmmmm

I didn't spot it first time around but looked up the 510k submission part re the approval.

TEK news 10th feb

from the Chairman

Additionally, we anticipate that Belluscura is likely to receive FDA clearance for their portable oxygen concentrator within the next 90 days. "


Belluscura site

Correct same submission likely nailed on FDA approval

However Tek didn't mention this bit

By comparison, a Premarket Approval (PMA) is used to demonstrate to the FDA that a new or modified device is safe and effective. This standard is higher than is required for 510(k) submissions. Much like a new drug, human use data from a formal clinical study is almost always required in addition to laboratory studies.

Belluscura anticipates that its artificial lung technology could be subject to PMA requirements.

[the patient investor] 31/3/2020 09:12

awaiting FDA approval very soon, this product will be a huge help in addition to ventilators in the treatment of breathing difficulties of covid19 patients

[hope67] 30/3/2020 10:26

Hello Tek community,

We hope you are staying safe. Tekcapital’s mission has always been to improve the quality of life through technology, and that dream is becoming realized in our Salarius portfolio company. With their groundbreaking low-sodium technology called MicroSalt, Salarius is releasing a new line of potato crisps that have roughly half the sodium of the market-leading crisp, while matching the salty savor of their full sodium counterparts. This is made possible by MicroSalt’s natural, micron-sized salt particles, which afford the same saltiness at about half the volume of regular salt, because they are absorbed twice as quickly by taste buds.

In an exciting development, SaltMe! snacks have been fast-tracked to be introduced to 71 food retail stores in May 2020, introducing the new product line to the relatively health-conscious American Northeast market. This will rapidly introduce the products, and MicroSalt in general, to thousands of customers, and bypass the typically cumbersome process of getting a new food product into distribution. Read coverage of the release in Proactive Investors.

The American CDC has indicated that sodium consumption of less than 2.3g per day is recommended for adults, however the “vast majority” of adults consume 50% more than this recommended limit. Data from the UK in 2016 points to average adult consumption of 8g per day of sodium, and that reducing this to even 6g per day can prevent about 8,000 premature deaths per year. These data points highlight the immediate need for low-sodium technologies like MicroSalt to help reduce sodium intake and improve heart health.

A new study from Cargill points to the importance of low-sodium options, indicating that when choosing a salty snack consumers care most about the sodium content, followed by the apparent naturalness of the ingredients. This food industry trend heralds the great potential of SaltMe! snacks in the market, which are both low sodium and all-natural.

Tekcapital owns 91.7% of Salarius Ltd.